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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 9, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

This registry will help us develop better methods of:

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

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

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Kidney Cancer DNA Registry
Study Start Date : March 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

saliva specimen

tissue (when available)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02087852     History of Changes
Other Study ID Numbers: 13-218
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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

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