Clinical Research

This Simple Blood Test Can Predict Cancer Years Before Symptoms Appear

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A new type of non-invasive cancer test has just delivered promising results in an early-stage feasibility study, paving the way for a future when we’ll be able to get highly accurate cancer screening with a simple blood test.

The technology, which involves scanning the blood for bits of DNA shed by tumours, is also referred to as a ‘liquid biopsy’, and these new results are getting us one step closer to a major upgrade in cancer diagnostics.

Right now, our best method for detecting cancer is a biopsy – cutting out a small piece of the tumour tissue for lab analysis. But biopsies are often painful and invasive, and you need to already have a tumour or at least a suspect tumour to cut something out of it.

That’s why scientists have been working on devising blood tests that can do the same thing without any surgery, and with the promise of delivering a diagnosis much earlier.

Finding cancer in the blood is possible when scientists focus on DNA fragments shed into the bloodstream by tumours. This is called circulating tumour DNA (ctDNA).

In recent years, scientists have been working on finding the best method for detecting ctDNA, using samples from patients who already have diagnosed cancer.

The latest study, which was just presented at the 2017 meeting of the American Society of Clinical Oncology (ASCO), has turned up the dial on what scientists can find when they scan for ctDNA.

“Our findings show that high-intensity circulating tumour DNA sequencing is possible and may provide invaluable information for clinical decision-making, potentially without any need for tumour tissue samples,” says lead researcher Pedram Razavi from Memorial Sloan Kettering centre.

The team used blood and tissue samples from 124 metastatic breast cancer, lung cancer, and advanced prostate cancer patients.

They scanned the samples for 508 different gene mutations, going over the specific regions of the genome up to 60,000 times. According to the scientists, this method generates 100 times more data than other sequencing approaches.

To see whether the method could catch any tumour DNA floating around in the blood, the team compared the results with those from tissue samples and genetic material from the patients’ own white blood cells.

“Our combined analysis of cell-free DNA and white blood cell DNA allows for identification of tumour DNA with much higher sensitivity, and deep sequencing also helps us find those rare tumour DNA fragments,” says Razavi.

The researchers detected 864 genetic changes across all three types of cancers in the tissue samples, and found 73 percent of those in the blood tests as well.

In 89 percent of the patients, they found at least one mutation in both tumour tissue and in blood. For breast cancer, for which liquid biopsies are more established, the success rate was 97 percent.

A huge benefit of having sensitive ctDNA tests is the chance of finding cancer years earlier than is possible with a biopsy, catching it before it has time to spread through the body.

The new method was developed with researchers from Grail, a genomics company dedicated to early cancer detection, backed by philanthropic funding from people like Jeff Bezos and Bill Gates.

Grail’s Mark Lee, who was one of the study co-authors, told Reuters that the company is now planning to use this new test to gather large-scale data from hundreds of thousands of people, both with and without cancer.

While the results are promising so far, the team will be needing a lot more research before this technology becomes an early detection tool that we all can benefit from in a routine check-up.

“It’s an important first step. We show that what we call a high-intensity approach works,” Razavi told Reuters.

The results were presented at the ASCO Annual Meeting, and have been accepted for publication in the Journal of Clinical Oncology.

Source: 1

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Sitting down all day ‘may accelerate DNA ageing’

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Image result for sitting down all day

“Women who lead a sedentary lifestyle have faster-ageing cells than those who exercise every day,” BBC News reports.

This research looked at telomeres – often likened to the caps at the end of shoelaces, they are made up of molecules that protect strands of chromosomes from “fraying”.

Telomeres shorten every time the genetic information in cells is duplicated. It’s believed that this leads to cell ageing and death.

In a sample of older women, the researchers looked at whether there was an association between time spent sitting down and telomere length.

Telomeres are measured in the small sections of nucleic acids that make up DNA, known as base pairs.

Among women in the study who did less than about 40 minutes of physical activity a day, those who sat longest had shorter telomeres by an average 170 base pairs.

The researchers say telomeres shorten at a rate of 21 base pairs a year – using a rough “back of a fag packet” calculation, 170 equals about eight years.

Sitting time did not seem linked to telomere length for women who did at least 30 minutes of physical activity a day.

We don’t know whether the results apply to men or younger people.

And, importantly, as the study only looked at the women’s activity levels and telomeres at one point in time, we don’t know whether activity levels or sitting causes telomeres to shorten.

Still, arguably, most of us would benefit from spending less time sitting down.

Image result for sitting down all day

Where did the story come from?

The study was carried out by researchers from the University of California, San Diego State University, the State University of New York at Buffalo, the University of Washington, the Fred Hutchinson Cancer Research Centre, George Washington University, the University of Florida and Northwestern University, all in the US.

It was funded by the US National Heart, Lung and Blood Institute.

The study was published in the peer-reviewed American Journal of Epidemiology on an open access basis, so it’s free to read online.

All of the UK media outlets that covered the study implied that a direct cause and effect relationship between sitting down and cell ageing had been proven.

For example, the Mail’s headline stated that, “Women who spend at least 10 hours on their backsides each day speed up their aging process.”

This is untrue. While there certainly seems to be an association worthy of further research, no causal link has been established.

What kind of research was this?

This cross-sectional study used data from women taking part in a much bigger study of health called the Women’s Health Initiative.

Cross-sectional studies can find correlations between different factors – in this case, sitting time and telomere length.

But because this type of study only looks at one point in time, researchers can’t say which factor happened first, so it’s not very useful for telling us whether one causes the other.

What did the research involve?

Researchers used information about 1,481 women aged over 65 who’d taken part in various sub-studies of the Women’s Health Initiative.

They used information from women who’d had their physical activity measured using accelerometers (devices that measure movement) and had also given DNA samples that had been tested for telomere length.

After accounting for other factors, they looked at whether telomere length was linked to the amount of time spent sitting.

The information about physical activity was measured over one week, during which time women wore their accelerometer all the time, except when bathing or swimming.

Women taking part also completed a questionnaire about their physical activity and kept a record of their sleep. Telomere length was measured from DNA in blood cells.

The researchers took account of the following possible confounding factors:

  • age and ethnic background
  • education level
  • marital status
  • smoking and alcohol consumption
  • body mass index
  • hours of moderate to vigorous physical activity each day
  • long-term diseases
  • use of hormone medicines

They also redid their calculations to divide the women into those who did more or less than the average amount of physical activity (about 40 minutes).

They then looked at the link between time spent sitting and telomere length for women who did more or less than 40 minutes physical activity a day.

They also looked at the link between sitting and telomere length for women who did 30 minutes or more a day, the recommended activity level for all adults.

It’s unclear whether these additional calculations were planned from the start of the study, or whether the researchers decided to do them because the initial findings did not show a link between time spent sitting and telomere length.

What were the basic results?

The length of time spent sitting was not linked to telomere length for women who did 30 minutes or more of moderate physical exercise a day.

For women who did less than the average amount of moderate physical activity each day, time spent sitting did show a link to telomere length.

Among these women, those who spent more than about 10 hours a day sitting had shorter telomeres than those who spent less than about eight hours a day sitting. The average difference was 170 base pairs (95% confidence interval [CI] 4 to 340).

Women who spent the most time sitting were more likely to be older, white, obese and have long-term illnesses.

How did the researchers interpret the results?

The researchers said their results suggest that, “Prolonged sedentary time and limited engagement in moderate to vigorous physical activity may act synergistically to shorten leukocyte telomere length among older women.”

In other words, being both sedentary for long periods and not getting much physical activity may act together to shorten telomeres in blood cells.

They speculated that causes of the link might include insulin resistance, lack of the anti-inflammatory responses the body has to exercise, or obesity.

They also acknowledged women who have long-term illnesses are more likely to have a sedentary lifestyle, and the illness rather than the lack of exercise may cause shortened telomeres.

Conclusion

It’s not news to anyone that being more physically active and spending less time sitting around is likely to keep people in better health.

But this study has many limitations that make it difficult for us to rely on its results.

While they are used as a marker for ageing cells, telomeres are not a direct measure of ageing. Although shortened telomeres have been linked to certain diseases, everyone’s telomeres shorten over time.

Saying shorter telomeres make someone “biologically older” doesn’t mean much. This hasn’t stopped the emergence of private companies offering to measure your telomeres – but it’s unclear what exactly you could usefully do with that information.

And the only cells studied in this research were blood cells, so we don’t know whether the results would have held for brain cells, muscle cells or any other cells in the body.

Doctors have tried to disentangle the effects of physical activity from the effects of being sedentary before without much success.

Generally, as in this study, research seems to show that if you get plenty of moderate to vigorous physical exercise, the amount of time you spend sitting or lying down doesn’t make much difference.

The researchers carried out a lot of comparisons and used multiple models to try to show sedentary time was linked to telomere length.

In most of these models, once you take account of women’s age, ethnicity, body mass index and long-term illnesses, there was no link.

Only when the researchers stratified the results by how much physical activity women did could they show a link in one category: those who did the least physical activity.

That suggests sedentary behaviour is not the strongest factor to affect telomere length.

Another problem with the study is it only looked at telomere length and physical activity at one point in the women’s lives.

We don’t know how much physical activity they’d done throughout their lives, or whether their telomeres had shortened faster than other women recently or at an earlier stage in life.

The study doesn’t add much to what we already know: physical activity is likely to be beneficial for people at all stages of life, and everyone should aim to get at least the recommended level of 30 minutes of moderate to vigorous physical activity a day.

Source: 1, 2, 3

Lifestyle Delivery Systems plans to conduct clinical trials of CannaStrips in Canada

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Lifestyle Delivery Systems Inc.(LDS) has begun outlining the protocols for clinical trials of its patent pending CannaStrips formula.

LDS’ chief medical officer, John Sanderson MD, having over 30 years of clinical research, clinical trial coordination and analysis experience, will oversee the protocols and operational aspects of the trials. The trials will be conducted in Canada with the specific goal of substantiating the efficacy of the CannaStrip delivery system. The company intends to submit the results of the clinical trials for consideration to Canadian health officials as an alternative delivery method for medicinal marijuana in Canada.

The clinical trials’ primary focus will be on three specific aspects of the delivery system. First, the time required from application onto the buccal membrane to the introduction of active ingredients into the blood stream. Second, the volume or percentage of active ingredients delivered into the blood stream and the length of time that those ingredients become bioavailable in the blood stream to the patient. Third, to determine the extent to which the ingredients can be directed to specific areas of the body and brain.

Brad Eckenweiler, CEO of Lifestyle Delivery Systems, states, “The value of these trials goes far beyond the Canadian marijuana market. The Company believes that clinical evidence supporting the goals for LDS technology will set regulatory expectations significantly higher for the control, effectiveness and safety of all marijuana products worldwide.”

The patent pending CannaStrips formula is unlike any other delivery method currently available. The current market has lookalike strips that in truth are simple sheeted material that act more like edibles and have little if any sublingual delivery capabilities. CannaStrips nano-engineered technology addresses the challenge of efficient transport of therapeutic molecules, including cannabis-derived bioactives, across the oral mucous barrier for systemic delivery into the bloodstream. Low viscosity pores or temporary channels are created which foster the rapid transfer of cannabis nanoparticles from the buccal surface into the circulation. Each particle is coated with a nano-envelope which chaperones its cargo to target tissues within the body. The net effect is improved bioavailability as well as enhanced efficacy.

Dr Sanderson, states, “While edibles overcome the health and safety issues of inhalation as a method of cannabis delivery, they are inherently far less efficient, as much of the therapeutic effect of the plant is lost to incomplete absorption and early liver disposal. These clinical investigations are an exciting next step that takes us from the laboratory trials to a more rigorous examination of the incremental benefits of this unique system of delivery which provides a third option that addresses concerns about both safety and efficacy.”

Lifestyle Delivery Systems Inc’s technology produces infused strips (similar to breath strips) that are not only a safer, healthier option to smoking but also a new way to accurately meter the dosage and assure the purity of the product.

Source: 1

What You Need to Know About the Deadly ‘Superbug’ Infection Resistant to All FDA-Approved Antibiotics

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PHOTO: An illustration of a group of carbapenem-resistant Enterobacteriaceae bacteria. The image was based on scanning electron micrographic imagery.

The rise of drug-resistant bacterial “superbugs” have been a concern of public health officials for years, but the U.S. Centers for Disease Control and Prevention has reported a worse-case scenario — a woman with a bacterial infection that was resistant to all FDA-approved treatments.

A Nevada woman died in September after being infected with type of drug-resistant bacteria called Klebsiella pneumonaiae that was resistant to all antibiotics available in the U.S., the CDC reported on Friday.

The woman was in her 70’s when she arrived at hospital in August 2016 with signs of sepsis. She had been in India years before and had been treated for a broken leg and bone infection, according to the CDC. After doing tests, her doctors found the bacteria — which belonged to a class of drug-resistant bugs called carbapenem-resistant Enterobacteriaceae (CRE) — were resistant to all forms of FDA-approved antibiotics. The patient died in September after going into septic shock, according to the CDC.

The woman’s extremely rare infection has focused attention on the increasing problems surrounding these drug-resistant infections and the lack of antibiotics available to treat them.

Fewer New Antibiotics Being Developed

No matter how effective an antibiotic is at killing bacteria, new drugs will be needed as the bacteria mutate and grow more resistant to the existing drugs.

“Antibiotic resistance occurs as part of a natural evolution process, it can be significantly slowed but not stopped,” the CDC notes on its website. “New antibiotics will always be needed to keep up with resistant bacteria as well as new diagnostic tests to track the development of resistance.”

However, the number of drug applications for novel antibiotics being developed by pharmaceutical companies have been dropping steadily over the last three decades, according to the CDC.

From 1980 to 1984, there were nearly 20 FDA drug applications approved for new antibiotics, but from 2005 to 2009, there were fewer than five applications approved, according to the CDC.

In 2013, the CDC said developing new antibiotics and new diagnostic tests was one of its four core actions to stop antibiotic-resistant infections from increasing.

CRE Infections Are an ‘Urgent Threat’

In 2013, CDC characterized CRE infections as an “urgent” threat, meaning the bacteria is an “immediate public health threat that requires urgent and aggressive action.”

The bacteria cause 9,000 drug-resistant infections per year and 600 related deaths, according to the CDC.

While most drug-resistant CRE bacteria are still susceptible to one or more antibiotic, in the infection of the woman in her 70’s reported by the CDC, the bacteria was resistant to all FDA-approved antibiotics, an extremely rare event.

CRE include common bacteria such as E.coli and Klebsiella bacteria.

Doctors Can Attempt to Treat Even Drug-Resistant Infections

When a patient has a drug-resistant bacteria, doctors will sometimes have to use harsher antibiotics or high dosages in order to try and fight the infection.

If a patient has a drug-resistant infection, doctors will work with a lab to test different doses of various antibiotics in an effort to overwhelm and kill the bacteria, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center.

However, antibiotics can be taxing on the patient, especially if they are older and with underlying medical conditions.

“This is the kind of calculation you do with every patient,” Schaffner said. “Patients with underlying illnesses present a certain kind of challenge.”

The CDC authors reported that an intravenous version of an antibiotic called fosfomycin is available in other countries but not for use in the U.S. It’s unclear if the patient’s doctors attempted to get an FDA exemption to use the drug and treat the patient.

Long Exposure to Antibiotics and Long Hospital Stays Can Be Dangerous

While this recently reported case is frightening, it is also unusual. The patient had been in and out of hospitals in India for two years after fracturing the large femur bone in her leg and developing a bone infection.

Long hospitals stays, especially in India, and exposure to different antibiotics can increase the likelihood of eventually developing a drug-resistant bacterial infection. As travel around the globe is becoming easier, it’s increasingly important for doctors to find out where their patients may have acquired an infection, Schaffner said.

“India has a notorious reputation for this [type of bacteria,]” he noted. “Travel-related questions are becoming much more important … and just reinforce that we are a very small world.”

Source: 1

A New Anti-Aging Technique Just Made It to Clinical Trials

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Anti-Aging, Female Style

Menopause is a point of no return for women, considered irreversible until recently. Earlier in 2016, a team of experts was able to find a way to rejuvenate post-menopausal ovaries. After months of preclinical trials, experts from the Genesis Health Clinic in Athens are now launching the first clinical trials for the method.

The technique uses Platelet Rich Plasma (PRP) injections. But unlike other PRP transfusions, this one needs no donor. This PRP is made by centrifuging a person’s blood sample to isolate its growth factors. “It offers a window of hope that menopausal women will be able to get pregnant using their own genetic material,” Konstantinos Sfakianoudis, a gynecologist at Genesis, said.

The preclinical trials began in May 2016 and have yielded considerable results. PRP rejuvenated menopausal women’s ovaries, restoring fertility. Several were able to conceive after receiving PRP treatment. 75% of the 60 women treated became capable of conceiving through natural pregnancy or in vitro fertilization, and 9 actually got pregnant.

More than 75% showed overall hormone levels returned to youthful levels. It made women young again, so to speak.

 

Credits: Steve Gschmeissner/SPL
Credit: Steve Gschmeissner/SPL

Clinical Trials

Changing lifestyles have led to an increase in late pregnancies, and this comes with the usual complications associated with menopausal conception. Aside from this, there are also cases of women with difficulties in bearing children because of thin uterine lining. But after injecting PRP into the uterus of six women who had these conditions, they were able to bear children.

So this method doesn’t just restore a woman’s fertility, it can also alleviate some of the (many) negative effects associated with menopause. Konstantinos Pantos, Inovium Ovarian Rejuvenation Trials Director, explained:

“The goal of the trial is not to prove that we can reverse menopause, because over and over again in our treatments, we know that this is the result. We also know that the treatment triggers a whole body response that restores hormones to the levels of youth. Now, we want to see if the rejuvenation is a permanent one, and if we have discovered a connection between the loss of fertility and the damaging effects of aging in the body.”

The clinical trials have been approved by Greece’s National Ethics Committee and will start in February 2017. It isn’t free, however. Participation costs a hefty sum of $5,000. Similar trials are set to begin in multiple locations in the US by June 2017.

Source: 1