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Prospective Registry of Multiplex Testing (PROMPT)

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ClinicalTrials.gov Identifier: NCT02665195
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Mayo Clinic
University of Pennsylvania
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

This study is being done to learn more about how changes in certain genes may be linked to cancer. Some people with cancer got their disease because they inherited an abnormal (mutated) gene.

The researchers of this study want to better understand the risks that are linked to genetic changes in these less well-studied genes. By understanding these risks, we believe that doctors will be able to give better advice to families with mutations in these genes.


Condition or disease Intervention/treatment
Genetic Testing Other: saliva specimen Behavioral: questionnaire

Detailed Description:
PROMPT (Prospective Registry of Multiplex Testing) is an Internet-based, patient-directed ascertainment study. It is a partnership between Memorial Sloan Kettering, University of Pennsylvania, Mayo Clinic, and Dana Farber Cancer Institute in collaboration with Ambry Genetics, GeneDx, Myriad Genetics, Pathway Genomics, and Quest Laboratories (5 laboratories providing multiplex panel testing commercially).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: Prospective Registry of Multiplex Testing (PROMPT): Phase II
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Group/Cohort Intervention/treatment
Prospective Registry of Multiplex Testing
This is a prospective ascertainment study that will obtain medical information and biospecimens from two different types of families: 1) Families transmitting sequence variants in non-BRCA predisposition genes that are either functionally deleterious or likely to be functionally deleterious based upon the interpretation of the laboratory that performed the testing on the Index Participant (Initial PROMPT enrollee), and 2) Families transmitting variants of uncertain significance (usually rare missense variants) in non- BRCA predisposition genes. Attempts will be made to collect a biospecimen and a completed risk factor questionnaire from each participant.
Other: saliva specimen
Behavioral: questionnaire



Primary Outcome Measures :
  1. Acquire DNA samples [ Time Frame: 3 years ]
  2. Acquire pathology materials [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
saliva specimen


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted as a multi-center study with the involvement of attendings, genetic counselors, and research study staff at the participating institutions.
Criteria

Inclusion Criteria:

  • Individual with deleterious (pathogenic) or likely deleterious (likely pathogenic) mutation in a cancer susceptibility gene OR
  • Individual with a variant of uncertain significance (VUS) in a cancer susceptibility gene OR
  • Family members, either tested or not tested, who are part of a family known to be transmitting a deleterious or likely deleterious mutation or a variant of uncertain significance in a cancer predisposition gene

Exclusion Criteria:

  • Inability or refusal to participate in consent discussion
  • Subject is less than 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665195


Contacts
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Contact: Mark Robson, MD 646-888-4058
Contact: Kenneth Offit, MD, MPH 646-888-4050

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Judy Gerber, MD         
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Fergus Couch, PhD    507-538-3270      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Mark Robson, MD    646-888-4058      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Mark Robson, MD    646-888-4058      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Mark Robson, MD    646-888-4058      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Mark Robson, MD    646-888-4058      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Mark Robson, MD    646-888-4058      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mark Robson, MD    646-888-4058      
Contact: Kenneth Offit, MD, MPH    646-888-4050      
Principal Investigator: Mark Robson, MD         
Memorial Sloan Kettering @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Mark Robson, MD    646-888-4058      
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Susan Domchek, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Dana-Farber Cancer Institute
Mayo Clinic
University of Pennsylvania
Investigators
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Principal Investigator: Mark Robson, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02665195     History of Changes
Other Study ID Numbers: 16-017
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019