Official Title
Genomic Profiling in Cancer Patients
Brief Title
Genomic Profiling in Cancer Patients
Protocol ID
NCT01775072
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary
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. Most mutations in cancer
cells are not inherited (passed down from parents) but happen after birth in the cancer
itself. Most cancers have many mutations. Some of these mutations are important for the
cancer cells to survive while others are not. The goal of this study is test cancer for
certain mutations using leftover tumor tissue from a previous surgery or biopsy.
Participants will also be asked to provide a tube of blood cheek (also known as a buccal)
swab, or a saliva sample that contains normal genes for comparison.
The purpose of Part B of this study is to:
Understand how genetic changes in tumor effect the chance of responding to experimental
cancer treatment. Understand how the genes in the tumor change overtime in response to
targeted cancer treatment.
Enrollment Count
200 participants
Eligibility 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.
Filters
Solid Tumors
Hematologic Cancers
RECRUITING
CHILD
ADULT
OLDER_ADULT