Genomic profiling to identify mutations in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify abnormal genes, or mutations, in cancer patients by analyzing leftover tumor tissue from surgeries or biopsies. Participants will also provide blood, saliva, or buccal swab samples for comparison with their tumor samples. The study seeks to understand how these genetic changes affect responses to experimental cancer treatments and how they evolve over time during targeted therapies. By examining both cancerous and normal genes, researchers hope to gain insights into the genetic underpinnings of cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Part A:

* Patients with a history of cancer or patients without a documented cancer history undergoing a surgical procedure, endoscopy, biopsy, or liquid biopsy (for example cell free DNA testing) to confirm or exclude a cancer diagnosis, or
* Any participant having a test or procedure that has the potential to provide a specimen that can be banked for future research purposes, or
* Any participant who has already had a diagnostic or therapeutic procedure that has yielded tissue, blood or other bodily fluids presently in the archive but who has not yet been approached to participate is also eligible.

Part B:

* 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.

Part C:

* Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate site or have previously consulted with an MSK physician.
* Patient must have successfully consented to Part A of this study.

Part D:

* Patients with no personal cancer history at increased risk for cancer development due to family history, molecular cancer marker, know carrier status of a gene associated with increased cancer risk or prior/ongoing environmental exposures or lifestyle factors.

Exclusion Criteria:

All Parts:

* Unwilling or unable to provide informed consent.

Part C:

* All patients consenting to Part A are eligible to consent to 12-245, Part C. Most patients will be eligible to receive clinical germline testing with return of results to the patient/health care providers. However, several exclusion criteria apply and are outlined below

  1. Solid tumor patients: Secondary germline analysis using BAM files generated for MSK-IMPACT testing is not an option for patients with solid tumors and an acute or chronic hematologic neoplasm that would preclude the use of blood or saliva as a source of germline DNA. Such patient may be eligible for primary germline testing using a non-blood source of germline DNA as per standard clinical guidelines. Solid tumor patients who have had an allogenic bone marrow/stem cell transplant will only be considered eligible for germline testing under Part C if a sample adequate for germline testing had previously been collected prior to allogenic bone marrow/stem cell transplant.
  2. Hematologic cancer patients: For patients with a hematopoietic neoplasm, germline testing may be an option under Part C using nail clippings or another non-blood source of DNA as per standard clinical practice. For patients who have had an allogenic bone marrow/stem cell transplant, clinical germline testing will only be considered under Part C if a sample adequate for germline testing had previously been collected prior to Allogenic bone marrow/stem cell transplant.

Part D

* Exclusion criteria are same as those for Part C outlined above.

Where it's running

• Norwalk Hospital
  Norwalk, Connecticut, United States Recruiting
• Baptist Alliance MCI
  Miami, Florida, United States Recruiting
• Memorial Sloan Kettering Basking Ridge
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen
  Montvale, New Jersey, United States Recruiting
• Kings County Hopsital Center
  Brooklyn, New York, United States Recruiting

Study contacts

• Principal investigator: David Solit, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: David Solit, MD
• Phone: 646-888-2641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.