Genomic Profiling for Cancer

Recruiting at 21 trial locations

Overseen By Zsofia Stadler, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Solid tumors, Hematologic neoplasm, others

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify abnormal genes (mutations) in cancer cells to understand how these changes might affect responses to new cancer treatments. Researchers will examine leftover tumor tissue and compare it with samples like blood or saliva from participants. This trial suits individuals with solid or blood-related cancers who have undergone a surgical procedure or biopsy, or those at risk for cancer due to family history or genetic markers. The goal is to observe how tumor genes change over time with treatment and potentially improve future therapies.

As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to more personalized and effective cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for patients with solid tumors?

Research has shown that both Clinical Germline Analysis and Molecular Profiling of Tumors have been studied for safety. For Clinical Germline Analysis, studies have found that collecting DNA samples from saliva or nails is generally easy and well-tolerated. This method helps identify mutations linked to cancer and typically doesn't cause side effects.

Similarly, Molecular Profiling of Tumors has been tested in many patients with solid tumors. Research indicates that analyzing tumor DNA is safe, with patients not experiencing severe side effects. This makes it a reliable way to understand the genetic details of tumors.

Overall, existing research considers both techniques safe. Prospective trial participants can feel confident that previous participants have handled these processes well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genomic profiling in cancer patients because it offers a personalized approach to treatment. Unlike traditional chemotherapy or radiation therapy, which treats cancer more generally, genomic profiling allows doctors to tailor treatments based on the specific genetic makeup of a patient's tumor. This method can uncover unique mutations that drive cancer growth, enabling the use of targeted therapies that are potentially more effective and have fewer side effects. By focusing on the tumor's genetic profile, doctors can choose the most promising treatments, paving the way for more successful outcomes.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that studying the unique characteristics of tumors can improve patient outcomes. In this trial, participants with solid tumors will undergo molecular profiling and clinical germline analysis. By identifying specific changes in tumors, doctors can select treatments that are more effective for each patient. For instance, if a tumor has a change that a specific treatment can target, doctors can use that treatment to enhance results. Previous studies have found that these targeted treatments can lead to better survival rates and responses in various cancers. Additionally, examining inherited genetic information helps researchers understand cancer risk and how the cancer might respond to treatment, providing a clearer picture of its behavior. ^{1 2 3 4 6}

Who Is on the Research Team?

David Solit, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with a history of cancer or patients w ithout a documented cancer history undergoing a surgical procedure, biopsy, or liquid biopsy (for example cell free DNA testing) to confirm or exclude a cancer diagnosis.

Patients must be successfully registered to Part A of MSKCC IRB# 12-245 Prior written approval for patient consent obtained from the Principal/Co-Principal Investigator of MSKCC IRB # 12-245.

Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate site or have previously consulted with an MSK physician.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants provide tumor tissue, blood, cheek swab, or saliva samples for genetic analysis

1-2 weeks

1 visit (in-person)

Genomic Profiling

Genomic profiling of tumor samples using techniques such as whole exome sequencing, whole genome sequencing, or RNA sequencing

1 year

Follow-up

Participants are monitored for genetic changes in response to experimental cancer treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Germline Analysis
• Molecular Profiling of Tumors

How Is the Trial Designed?

Group I: Pts with solid tumors Experimental Treatment 2 Interventions

Patients must have solid or hematologic cancer. for treatment on a . Patients must have undergone pathologic confirmation of their tumor at MSKCC and have either: 1) archival tissue available for analysis, 2) have fresh tissue collection planned as routine standard of care biopsy or part of a research biopsy under another clinical trial(or peripheral blood / bone marrow collection in the case of hematologic cancers) outside of the context of this protocol, or 3)archival tissue .available at an outside facility. For prospective genotyping tissue specimens from the primary site, a metastasis or recurrence will be used based upon the availability and quality of tissue.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432218

Germline Predisposition in Hematologic Malignancies Including germline genetic testing for patients with hematopoietic malignancies will require accurate, cost-effective platforms, and health care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9669814/

Characterization of Oncology Clinical Trials Using Germline ... This cross-sectional study evaluates the features of oncology clinical trials that use germline genetic data.

3. nature.com nature.com/articles/s41467-023-42585-9

Enhanced clinical assessment of hematologic ... A comprehensive data set of somatic alterations from paired tumor and normal DNA using a hybridization capture-based next generation sequencing platform.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01775072

NCT01775072 | Genomic Profiling in Cancer Patients The purpose of this study is to determine whether certain genes in cancer may be abnormal. When a gene is abnormal this is called a mutation.

5. jci.org jci.org/articles/view/190264

Detecting likely germline variants during tumor-based ... Deleterious germline variants have been implicated in many cancer susceptibility genes (CSGs), several of which give rise to clinical phenotypes ...

6. aacrjournals.org aacrjournals.org/cancerdiscovery/article/15/11/2213/766783/Germline-Mutations-as-Cancer-Drug-Targets?searchresult=1

Germline Mutations as Cancer Drug Targets - AACR Journals This phase I/IIa clinical trial (NCT01461148) tested the safety and immunogenicity of a neoantigen-based vaccine containing three shared ...