Kidney Cancer DNA Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02087852
First received: March 12, 2014
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This registry will help us develop better methods of:

  • Preventing these cancers
  • Diagnosing these cancers
  • Treating these cancers

Condition Intervention
Renal Cancer
Other: salvia for germline DNA
Behavioral: the Kidney Cancer Questionnaire
Behavioral: Family History Questionnaire (when applicable)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Kidney Cancer DNA Registry

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • establish a kidney cancer registry [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    with detailed epidemiologic data and germline DNA available for next generation sequencing from consenting patients, selected family members, and healthy unrelated controls.


Biospecimen Retention:   Samples With DNA

saliva specimen

tissue (when available)


Estimated Enrollment: 750
Study Start Date: March 2014
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
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.
Other: salvia for germline DNA Behavioral: the Kidney Cancer Questionnaire Behavioral: Family History Questionnaire (when applicable)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087852

Contacts
Contact: Jonathan Coleman, MD 646-422-4432
Contact: Kenneth Offit, MD 646-888-4050

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jonathan Coleman, MD    646-422-4432      
Contact: Kenneth Offit, MD    646-888-4050      
Principal Investigator: Jonathan Coleman, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jonathan Jonathan, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02087852     History of Changes
Other Study ID Numbers: 13-218
Study First Received: March 12, 2014
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Questionnaire
DNA
saliva
kidney cancer
13-218

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014