Increasing Genetic Testing for Families at Risk of Cancer

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 study evaluates new models of cancer genetic counseling aimed at enhancing patient engagement with genetics teams. It consists of two trials, with the first focusing on cascade genetic testing, where healthcare providers reach out to family members of patients who have tested positive for harmful gene mutations. The goal is to assess the practicality and effectiveness of this approach compared to traditional methods where patients inform their relatives. By facilitating direct communication, the study aims to increase the rate of genetic testing among at-risk individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

EfFORT Trial Probands

* Current MSK patient
* Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months (or within the last year for the de-identified non-randomized control probands)
* 25 years of age or older
* Self-reported "very well" comprehension of written and verbal English language or Spanish language
* Has at least one ARR who meets criteria for study enrollment (see below)
* First in the family to test positive for PV at MSK in any of the following cancer susceptibility genes, or an ARR of an MSK proband who converted to the proband role:

APC I1307K, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDKN2A (P16), CHEK2, EPCAM, GREM1, MLH1, MSH2, MSH6, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, SMAD4, BAP1, DICER1, FH, FLCN, HOXB13, KIT, MAX, MEN1, MET, MITF, PTCH1, RAD51B, RET, SDHB, SDHC, SDHD, STK11, SUFU, TMEM127, TSC1, TSC2, VHL

Principal Investigator discretion will be used to determine whether specific variants within the above genes meet a clinical actionability threshold to warrant familial genetic testing.

EfFORT Trial At-Risk Relatives (ARRs):

* Biological first-, second-, or third- degree relative of enrolled MSK proband
* 25 years of age or older
* Resides within the United States
* Self-reported medical insurance which can be in or out of network with MSK
* Self-reported "very well" comprehension of written and verbal English language

STRIVE Trial VUS Patients

* Current MSK patient
* Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months
* 25 years of age or older
* Self-reported "very well" comprehension of written and verbal English language or Spanish language
* Has a VUS identified in any of the following cancer predisposition genes:

APC, ATM, AXIN2, BAP1, BARD1, BLM, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A (P16), CHEK2, CTNNA1, DICER1, ELOC, EPCAM, FH, FLCN, GREM1, HOXB13, KEAP1, MAX, MBD4, MEN1, MET, MITF, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NF1, NF2, NTHL1, PALB2, PMS2, POLD1, POLE, POT1, PTEN, RAD51B, RAD51C, RAD51D, RB1, RET, RNF43, RPS20, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, STK11, TERT, TMEM127, TP53, TSC1, TSC2, VHL

STRIVE Trial PCP Providers:

* Designated healthcare provider for an enrolled VUS patient
* Resides within the United States

Exclusion Criteria:

EfFORT Trial Probands

* Is unwilling or unable to provide informed consent
* Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
* Does not have an email address
* Has enrolled in the STRIVE trial

EfFORT Trial At-Risk Relatives (ARRs):

* Is unwilling or unable to provide informed consent
* Is unwilling or unable to create a MyMSK patient portal account
* Has previously undergone genetic testing for the familial PV
* Does not have an email address
* Has opted out of study contact

STRIVE Trial VUS Patients

* Is unwilling or unable to provide informed consent
* Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
* Does not have an email address
* Has enrolled in the EfFORT trial

STRIVE Trial PCP Providers

* Contact information not available

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activity)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kenneth Offit, MD, MPH — Memorial Sloan Kettering Cancer Center
• Study coordinator: Kenneth Offit, MD, MPH
• Email: offitk@mskcc.org
• Phone: 646-888-4059

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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.