Genomic Profiling in Cancer Patients

Inclusion Criteria:

Part A:

• Patients with a history of cancer or patients without a documented cancer historyundergoing a surgical procedure, endoscopy, biopsy, or liquid biopsy (for examplecell free DNA testing) to confirm or exclude a cancer diagnosis, or

• Any participant having a test or procedure that has the potential to provide aspecimen that can be banked for future research purposes, or

• Any participant who has already had a diagnostic or therapeutic procedure that hasyielded tissue, blood or other bodily fluids presently in the archive but who hasnot 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-PrincipalInvestigator of MSKCC IRB # 12-245.

Part C:

• Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate siteor 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 developmentdue to family history, molecular cancer marker, know carrier status of a geneassociated with increased cancer risk or prior/ongoing environmental exposures orlifestyle 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. Mostpatients will be eligible to receive clinical germline testing with return ofresults to the patient/health care providers. However, several exclusion criteriaapply and are outlined below

1. Solid tumor patients: Secondary germline analysis using BAM files generated forMSK-IMPACT testing is not an option for patients with solid tumors and an acuteor chronic hematologic neoplasm that would preclude the use of blood or salivaas a source of germline DNA. Such patient may be eligible for primary germlinetesting using a non-blood source of germline DNA as per standard clinicalguidelines. Solid tumor patients who have had an allogenic bone marrow/stemcell transplant will only be considered eligible for germline testing underPart C if a sample adequate for germline testing had previously been collectedprior 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 anothernon-blood source of DNA as per standard clinical practice. For patients whohave had an allogenic bone marrow/stem cell transplant, clinical germlinetesting will only be considered under Part C if a sample adequate for germlinetesting had previously been collected prior to Allogenic bone marrow/stem celltransplant.

Part D

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