Genomic Profiling in Cancer Patients

  • STATUS
    Recruiting
  • End date
    Jan 21, 2024
  • participants needed
    200
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 7 October 2022
cancer
cancer treatment

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.

Details
Condition Solid Tumors, Hematologic Cancers
Treatment molecular profiling of tumors, Clinical Germline Analysis
Clinical Study IdentifierNCT01775072
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Part A
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
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

Unwilling or unable to provide informed consent
All Parts
Part C and D
Patients who have had an Allogenic bone marrow/stem cell transplant
Patients with an acute or chronic myeloid neoplasm, histiocytic neoplasm, or other myeloproliferative disease (e.g. MDS, MPN, MDS/MPN) that would preclude the use of blood or saliva as a source of germline DNA. For example, patients with a hematologic malignancy with a high circulating disease burden (defined as >10% of WBCs from flow cytometry or CBC differential)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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