A Behind-The-Scenes Look At Clinical Trials

By Aileen Lee

Beginning a clinical trial is a lot like preparing for a wedding or another large celebratory event with many details and different people working together. In the case of starting a clinical trial, the “big day” is your first day of treatment.  Planning a wedding entails coordination with multiple vendors – venues, florists, catering – all within a set period of time. Similarly, there is a set timeline for determining eligibility and enrolling on a clinical trial. We call this process “screening” and everyone who is interested in starting a clinical trial must go through screening prior to enrolling on the trial. The screening process requires collaboration with:

  • Physicians and nurses who work directly with you to perform specific procedures and tests necessary for eligibility
  • Lab technicians who process your blood or other samples according to study specific protocols
  • Sponsors (such as pharmaceutical companies) to verify your eligibility for the trial
  • Pharmacists to ensure you are dispensed the proper drug and dose
  • Federal oversight (such as the FDA) to ensure proper safety reporting for you as well as past and future patients exposed to the treatment

Coordination can be difficult. That’s where I come in.

Just as a wedding planner assists brides, as a study coordinator, I assist patients. I work diligently behind the scenes with a range of health care providers and clinical research colleagues to ensure that each step of the screening process is feasible for patients to complete, and to help ensure that there are no delays in starting treatment.

IT’S LIKE A CLOCK COUNTING DOWN

So what exactly is screening? Here are three things to know:

  1. Screening begins the moment you enroll (most often by signing a consent document)
    It’s a checklist of items that must be completed within certain windows of time to verify your eligibility for a trial. The timeline varies depending on the study protocol, but on average, scans and labs must be completed within 28 days of receiving the first treatment. Sometimes, labs must be completed within 14 days prior to starting a clinical trial.
  2. Screening does not guarantee eligibility
    It’s not enough to complete a test. Sometimes, your test results must fall within a certain range. Often, this is for safety reasons, but it can also be because the drug is only thought to work in certain populations or with certain pre-established disease parameters.
  3. The biggest challenges are coordination and accommodation
    In reality, completing this checklist is not always simple, but we do our best to simplify it and accommodate you.

Screening consists of standard-of-care procedures – tests you’ve likely completed from previous visits with your provider, like blood tests to determine white blood cell count, hemoglobin levels, etc. – and study specific procedures – tests that are normally not conducted, but that the trial would like to test, such as magnesium, phosphorous or amylase.

If you have had standard of care procedures prior to consenting that we can use to verify your eligibility, we will use them, but depending on when they happened, this may decrease the amount of time we have to complete the other required tests, since all testing must occur within a certain window of time.

IT REQUIRES SUPPORT

Beginning a clinical trial can be a daunting task, but rest assured that in addition to the support of your family and your healthcare team, you also have a network of clinical trial personnel cheering you on during each step of the way.

To find a clinical trial that may be right for you, check out our new A-Z search feature.

WMC_GU_Team

Aileen Lee_Headshot
Aileen Lee is a genitourinary (GU) cancer clinical trial coordinator. Through the Weill Cornell Medicine and NewYork-Presbyterian Joint Clinical Trial Office (JCTO), Aileen screens patients interested in participating in a clinical trial for kidney, bladder, prostate or testicular cancer. She also contributes to Dr. Molina’s Kidney Cancer Support Group. She is an Oregon native, violinist and aspiring physician.

Survival Improves in mRCC With Surgical Metastasectomy

Ana Molina MDThis is an excerpt of an article that appeared in Medscape in which Dr. Ana Molina comments on recent research published in the Journal of Urology. Read the full story here.

In patients with metastatic renal cell carcinoma (mRCC), the surgical removal of metastases — complete metastasectomy (CM) — is associated with significantly longer overall survival compared with incomplete metastasectomy. This conclusion comes from a meta-analysis that included more than 2000 patients and was reported in the January issue of the Journal of Urology.

Patients who did not undergo CM were 2.4 times more likely to die of their disease than were patients with mRCC who underwent CM, report the authors.

Medscape Medical News reached out to medical oncologists who were not associated with the study for their expert insights.

“Although there are limitations to the observational data presented in this article, the work reflects our move away from the conventional thinking that surgery is reserved for localized disease and systemic therapy is for metastatic disease,” Ana Molina, MD, medical oncologist at Weill Cornell Medicine and New York-Presbyterian, New York City, told Medscape Medical News. “The role of surgery in the management of patients with advanced RCC is of great interest and significance,” she added.

The researchers argue that although the National Comprehensive Cancer Network already recommends this approach (and nephrectomy), it may also be appropriate in patients with metastases at multiple organ sites. Indeed, in six of the studies chosen for the meta-analysis, 36% to 56% of patients had metastases to multiple organs. A sensitivity analysis, which excluded patients with single-organ metastases, found a persistent survival benefit for patients who underwent CM.

“In our clinical practice, we are referring patients to undergo metastasectomy when possible. Typically these patients have oligometastatic RCC,” Dr Molina said.

Dr Molina indicated that the role of systemic therapy after metastasectomy is being formally studied in a prospective study. The ECOG-ACRIN (NCT01575548) cooperative group study is enrolling patients with completely resected metastatic clear cell RCC to pazopanib vs placebo for 12 months.

In addition, a randomized study comparing the programmed cell death ligand-1 antibody atezolizumab vs placebo recently opened for patients with high-risk RCC after nephrectomy. This study is also enrolling fully resected patients after metastasectomy (NCT03024996), Dr Molina pointed out.

“Results from these studies will provide much-needed information on the role of systemic therapy and metastasectomy for patients with advanced RCC,” Dr Molina said.

Thinking Beyond Survival – Cerebrovascular Complications of Cancer

Babak Navi_headshotBabak B. Navi, MD, MS
Stroke Center Director
Assistant Professor of Neurology
Weill Cornell Medicine | NewYork-Presbyterian

Over the past decade, there has been tremendous progress in cancer therapeutics. This includes targeted agents that act on specific receptors in cancer cells, immunotherapy which harnesses the body’s immune system to attack cancer cells, and personalized medicine whereby oncologists use different combinations of cancer drugs to optimize the chance of success based on the molecular profile of the tumor. These amazing scientific advances have led to prolonged survival for people with several cancer types, and it is possible that in the not-too-distant future, cancer will become more of a chronic disease with periodic flare-ups similar to what has occurred with diabetes and HIV. However, with this paradigm shift, long-term quality of life and well-being has become more important, and preventing diseases and complications that can affect these factors is paramount.

Stroke is the leading cause of disability in the United States. In addition, in many parts of the world, including Asia, it is the leading cause of death. In the United States alone, 800,000 people each year suffer stroke and this number is expected to rise as average life expectancy increases. Many factors can increase a person’s risk for stroke including age, hypertension, diabetes, high cholesterol, obesity, and smoking. Besides these traditional stroke risk factors, we now know that cancer and its treatments also increase the risk of stroke. In particular, patients with certain types of cancer, such as lung, pancreatic, and bladder cancers, as well as patients with metastatic disease, tend to have the highest risk. For instance, elderly patients with newly-diagnosed lung cancer face roughly an 8% risk of stroke in the first year after being diagnosed with cancer. In addition, cancer patients’ stroke risk varies with time and is highest in the first 3 months after diagnosis, when some cancer patients face up to a 3-fold higher risk of stroke than usual. It also turns out that certain necessary and potentially life-saving cancer treatments, including some forms of chemotherapy and radiation, can increase stroke risk.

At the moment, the exact reasons why cancer patients face a heightened risk of stroke are unclear. It is well known that circulating cancer cells can alter individuals’ clotting systems to promote clot formation but exactly how they do this is uncertain. Furthermore, doctors know that certain chemotherapy and radiotherapy treatments can damage blood vessels, but once again, the exact mechanisms underlying these processes are poorly understood.

At Weill Cornell Medicine and NewYork-Presbyterian, my team is actively working to determine what the exact risks of stroke are in people with newly diagnosed cancer, what clinical factors and biomarkers in blood can help doctors identify high-risk patients, and what the optimal strategies are to prevent and treat stroke in cancer patients. One particular study that we are currently enrolling into is entitled MOST-Cancer. This study uses cutting-edge ultrasound and blood tests to evaluate the predictors and mechanisms of stroke in people with cancer. If you or a loved one has cancer and are interested in learning more about these studies, please email our team at stroketrials@med.cornell.edu or call 212-746-6757.

May is National Stroke Awareness Month. The main intent of this campaign is to raise awareness about the symptoms and signs of stroke and to educate the public to call 911 if they suspect stroke. The most popular campaign is FAST, which stands for Face, Arm, Speech, and Time – Time to call 911.

If you or a companion develops unexplained facial asymmetry, arm weakness, or speech changes, you should call 911 immediately so that an ambulance is activated to provide rapid delivery to the closest stroke center. This is imperative as there are medicines and surgical procedures that have been proven to improve outcomes after stroke but these are only effective in the first few hours after stroke onset. Therefore, if stroke is suspected, do not hesitate, call 911, as it could be life saving!

Furthermore, I recommend that cancer patients have a frank discussion with their doctors about their individual risks for stroke and other cardiovascular diseases, as well as potential strategies to reduce their risks through medicines and lifestyle modifications.

We’ve made great strides in oncological care so that patients routinely get cured or live many years with their disease. Therefore, it is now time that we turn our attention to long-term quality of life, and in particular, to preventing stroke and the other secondary complications of cancer.

Stroke_BE FAST SIGN NEW