Biopsy for Cancer Research

Recruiting at 16 trial locations

Overseen By Nancy A Moore, R.N.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must not be taking: Antibiotics, Antifungals, Antivirals

Disqualifiers: HIV, Hepatitis, Invasive fungal infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect tissue and fluid samples from cancer patients to advance cancer research. Researchers use these samples to study cancer at a molecular level and develop new models for testing treatments. The trial is open to cancer patients at the NIH Clinical Center and other sites, including those newly diagnosed, with recurring cancer, or currently undergoing treatment. Patients who undergo necessary medical procedures, such as a biopsy (a procedure to remove a small sample of tissue for examination), for their care and are willing to donate samples may be a good fit for this trial. As an unphased study, this trial offers patients a unique opportunity to contribute to groundbreaking cancer research and potentially improve future treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that antibiotics, antifungals, or antivirals for an infection should be completed at least 1 week before collection, and no symptoms should recur for at least 1 week after completing antibiotics. Prophylactic use of these medications is allowed.

What prior data suggests that this biopsy procedure is safe for patients?

Research has shown that biopsies conducted for clinical trials are generally safe. In one study, serious complications occurred in only 1.4% of cases. Most issues were minor, with pain being the most common, reported in about 11% of procedures. More serious problems were rare, occurring in just 0.4% of cases. Overall, research biopsies are well-tolerated and carry a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different methods of collecting and using tissue samples to advance cancer research. Unlike traditional biopsy techniques that primarily focus on diagnosis, this trial investigates how tissue samples can be used in preclinical models, including pediatric ones, to better understand cancer mechanisms and develop new therapies. By diversifying the ways in which tissue samples are utilized, the trial holds the potential to uncover novel insights into cancer biology and pave the way for more targeted and effective treatments in the future.

Who Is on the Research Team?

James H Doroshow, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Inclusion Criteria

(HDGC) syndrome.

--Who have a newly diagnosed malignancy for which they have not yet received treatment, or Radiographic evidence of tumor growth and/or new metastases, or documented evidence by the treating physician of signs/symptoms of clinical disease progression, or --Who are currently undergoing treatment and for whom disease response has not yet been assessed

In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Collection of tissue specimens and biological fluids from adult and pediatric patients for research purposes

Day of collection

Follow-up

Participants are monitored for any adverse effects following sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biopsy

How Is the Trial Designed?

Group I: 4/Preclinical Models, Pediatric Experimental Treatment 0 Interventions

Preclinical Models, Pediatric

Group II: 3/Preclinical Models Experimental Treatment 0 Interventions

Preclinical Models

Group III: 2/Standard and Preclinical Models Experimental Treatment 0 Interventions

Standard and Preclinical Models

Group IV: 1/Standard Experimental Treatment 1 Intervention

Standard

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1.

aacrjournals.org

aacrjournals.org/clincancerres/article/23/21/6450/259276/Underreporting-of-Research-Biopsies-from-Clinical

Underreporting of Research Biopsies from Clinical Trials in ...

Despite ethical obligations to report research biopsies, the majority (61%) of trials do not report results from research biopsies. Complications are rarely ...

2.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(23)02178-6/fulltext

2314P Quality and safety of research biopsies (RB) in ...

85% of samples had >10% TC and 60% had >50% TC. Any grade complications occurred in 15% of procedures, with pain being the most frequent (11%; 0.4% Grade 3-4).

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3228176/

Outcomes of Research Biopsies in Phase I Clinical Trials

Our study confirms that research biopsies are safe (1.4% serious complication rate) similar to studies done in other patient populations. The 1.4% risk of ...

4.

nature.com

nature.com/articles/s41598-021-02093-6

Variability in biopsy quality informs translational research ...

We report biopsy safety and quality outcomes for percutaneous core biopsies of hepatocellular carcinoma (HCC) performed as part of a prospective clinical trial.

5.

jhmhp.amegroups.org

jhmhp.amegroups.org/article/view/4974/html

The use of research biopsies in oncology trials

Unreported research biopsy results in clinical trials has no value and should not be performed. This reinforce the conclusion of Parseghian that ...