Status:
RECRUITING
An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
BRCA1 Mutation
POLD1 Gene Mutation
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the impact of new cancer genetic counseling models that aim to increase patient engagement with the genetics team. To do this, the study consists of two trials ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05420064
Start Date
December 1 2022
End Date
November 30 2026
Last Update
November 12 2025
Active Locations (8)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activity)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725