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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Discovering New Genetic Markers in Adults and Children Who May Be At Risk for Hereditary Forms of Cancer

Clinicaltrials.gov identifier NCT03922893

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted December 20, 2019

Study Description

Brief summary:

This study is being done to attempt to identify genetic mutations or other gene-based variations in adults and children who have cancer, or are likely to develop an inherited form of cancer, and potentially reduce their risk for cancer or treat the cancer earlier.

  • Condition or Disease:Cancer
  • Intervention/Treatment: Other: Family History Information
    Genetic: ORAGENE
    Genetic: Blood
    Other: Skin Biopsy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 1500 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Discovery and Characterization of Susceptibility Genes in Adults and Children With Suspected Hereditary Cancer Predisposition
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2029
  • Estimated Study Completion Date: April 2029
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Family Member Participants
Family members of the proband will be approached to consent to this protocol
Other: Family History Information
The family history ascertainment focuses on self-reported family history of first-, second-, and third-degree family members, including types of malignancies/ pre-malignant lesions and age at diagnosis.

Genetic: ORAGENE
Approximately 2-4mL of saliva may be collected in specialized Oragene DNA Self-Collection Kit tubes or buccal swab-based collection devices.

Genetic: Blood
For select participants, 1-2 tubes of blood will be drawn for DNA and RNA analysis

Other: Skin Biopsy
In certain circumstances, for Memorial Sloan Kettering participants and their family members, it may be necessary to obtain a skin biopsy.
: Proband
First individual in a family to consent to this protocol
Other: Family History Information
The family history ascertainment focuses on self-reported family history of first-, second-, and third-degree family members, including types of malignancies/ pre-malignant lesions and age at diagnosis.

Genetic: ORAGENE
Approximately 2-4mL of saliva may be collected in specialized Oragene DNA Self-Collection Kit tubes or buccal swab-based collection devices.

Genetic: Blood
For select participants, 1-2 tubes of blood will be drawn for DNA and RNA analysis

Other: Skin Biopsy
In certain circumstances, for Memorial Sloan Kettering participants and their family members, it may be necessary to obtain a skin biopsy.
Outcome Measures
  • Primary Outcome Measures: 1. Discovery of novel cancer susceptibility genes [ Time Frame: Up to 10 years ]
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Potential participants will be identified by members of the Clinical Genetics Service from the following sources: a) MSK patients previously tested through MSK IMPACT #12-245 protocol; b) MSK patients referred to the Clinical Genetics Service by an MSK physician, outside physician, or self-referral; c) non-MSKCC patients referred or self-referred to the Clinical Genetics Service or directly to the P.I. and identified as candidates for participation in this study; d) family members of probands identified by the study team to be informative for research purposed.
Criteria

Inclusion Criteria:

- Individuals who have undergone clinical and/or research genetic evaluation, found to
have or not have a germline genetic variant (pathogenic, likely pathogenic, variant of
uncertain/unknown significance, likely benign).

- Individuals with or without a personal history of malignant or pre-malignant lesions
who demonstrate: a) clinical findings suggestive of a genetic cancer susceptibility
syndrome including very early age at onset, multiple primary malignancies, or other
features; and/or b) family histories suggestive of a genetic cancer susceptibility
syndrome, or c) other features suggesting inherited etiology of malignancy as
determined by the PI.

- Family members of the above participants. Both children (with parental consent as age
appropriate) and adults are eligible to participation.

- Individuals may or may not be enrolled MSK patients; probands may be referred to (or
self-referred to) the study and may be enrolled at discretion of the PI and if able to
provide informed consent.

- Biospecimens derived from deceased family members may be used for research in this
study if consent if provided by the executor of the estate of that individual.

Exclusion Criteria:

- Patients will be excluded from this study if he/she has physical, cognitive or
psychiatric conditions that interfere with ability to give meaningful informed
consent.

Contacts and Locations
Contacts

Contact: Kenneth Offit, MD, MPH 646-888-4059 offitk@mskcc.org

Contact: Mark Robson, MD 646-888-5486 robsonm@mskcc.org

Locations

United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge

United States, New Jersey
Memoral Sloan Kettering Monmouth (Consent only)
Middletown

United States, New Jersey
Memorial Sloan Kettering Bergen (Consent only )
Montvale

United States, New York
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack

United States, New York
Memoral Sloan Kettering Westchester (Consent only)
Harrison

United States, New York
Memorial Sloan - Kettering Cancer Center
New York

United States, New York
Memorial Sloan Kettering Nassau (Consent only)
Uniondale

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Kenneth Offit, MD, MPH Memorial Sloan Kettering Cancer Center

More Information
  • Responsible Party: Memorial Sloan Kettering Cancer Center
  • ClinicalTrials.gov Identifier: NCT03922893 History of Changes
  • Other Study ID Numbers: 19-133
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: December 20, 2019
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Memorial Sloan Kettering Cancer Center: Genetic evaluation
    Germline genetic variant
    Genetic cancer
    Memorial Sloan Kettering Cancer Center
    19-133