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Kidney Cancer DNA Registry

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ClinicalTrials.gov Identifier: NCT02087852
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date March 12, 2014
First Posted Date March 14, 2014
Last Update Posted Date January 11, 2019
Study Start Date March 2014
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2014)
establish a kidney cancer registry [ Time Frame: 5 years ]
with detailed epidemiologic data and germline DNA available for next generation sequencing from consenting patients, selected family members, and healthy unrelated controls.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02087852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Kidney Cancer DNA Registry
Official Title Kidney Cancer DNA Registry
Brief Summary

This registry will help us develop better methods of:

  • Preventing these cancers
  • Diagnosing these cancers
  • Treating these cancers
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

saliva specimen

tissue (when available)

Sampling Method Non-Probability Sample
Study Population Urologists, clinical geneticists, and medical oncologists at MSKCC, along with study personnel will identify patients, family members, and unaffected controls that may be eligible for the registry. Patients and families may also be directly referred to the MSKCC study team by any MSKCC physician, external physician, or by the family itself.
Condition Renal Cancer
Intervention
  • Other: salvia for germline DNA
  • Behavioral: the Kidney Cancer Questionnaire
  • Behavioral: Family History Questionnaire (when applicable)
Study Groups/Cohorts
  • kidney cancer patients receiving care at MSKCC
    Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire (when applicable,), and providing a saliva sample for germline DNA. In cases where tissue samples from surgically derived tumor specimens are obtained these will used to determine genetic alterations related to cancer predisposition or pathogenicity.
    Interventions:
    • Other: salvia for germline DNA
    • Behavioral: the Kidney Cancer Questionnaire
    • Behavioral: Family History Questionnaire (when applicable)
  • relatives of patients with kidney cancer
    Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire (when applicable,), and providing a saliva sample for germline DNA. In cases where tissue samples from surgically derived tumor specimens are obtained these will used to determine genetic alterations related to cancer predisposition or pathogenicity.
    Interventions:
    • Other: salvia for germline DNA
    • Behavioral: the Kidney Cancer Questionnaire
    • Behavioral: Family History Questionnaire (when applicable)
  • healthy controls who are unrelated & do not have hx of cancer
    Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire (when applicable,), and providing a saliva sample for germline DNA. In cases where tissue samples from surgically derived tumor specimens are obtained these will used to determine genetic alterations related to cancer predisposition or pathogenicity.
    Interventions:
    • Other: salvia for germline DNA
    • Behavioral: the Kidney Cancer Questionnaire
    • Behavioral: Family History Questionnaire (when applicable)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 12, 2014)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Kidney Cancer Case Cohort:

  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must have a diagnosis or suspicion of kidney cancer

Family Member Cohort:

  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must be a blood relative of the proband. Family members of probands including mother, father, sisters, brothers, half-sisters, half-brothers, daughters, sons, grandmothers, grandfathers, as well as aunts and uncles are eligible. These individuals need not have kidney cancer, as they will be used for segregation analysis of suspected variants found in the proband; requesting DNA from relatives is required.

Control Cohort:

  • Must be ≥ 18 years of age AND
  • Must be an English-speaker AND
  • Must not have a personal history of cancer, with the exception of nonmelanoma skin cancer, AND
  • Must not be a blood relative of any cases or controls enrolled in this study

Exclusion Criteria:

  • Patients who, in the opinion of the primary MSKCC clinician or the investigator, have a condition that precludes their ability to provide an informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jonathan Coleman, MD 646-422-4432
Contact: Kenneth Offit, MD 646-888-4050
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02087852
Other Study ID Numbers 13-218
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan Jonathan, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2019