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Genomic profiling to identify mutations in cancer patients

Genomic Profiling in Cancer Patients

Observational Memorial Sloan Kettering Cancer Center · NCT01775072

This study is trying to find out how changes in genes from tumor and normal tissue samples can affect how cancer patients respond to new treatments.

Quick facts

Study typeObservational
Enrollment200 (estimated)
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Locations18 sites (Bridgeport, Connecticut and 17 other locations)
Trial IDNCT01775072 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with a history of cancer or those undergoing procedures that may yield specimens for genomic analysis.

Not a fit: Patients who do not have a history of cancer and are not undergoing any relevant procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective cancer treatments based on individual genetic profiles.

How similar studies have performed: Other studies utilizing genomic profiling in cancer have shown promising results, indicating that this approach is both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Bridgeport, Connecticut and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsHematologic Cancerstissuebloodsalviabuccal swabGenomic Profilinghematologic cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.