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Clinical Trials/NCT02087852
NCT02087852
Recruiting
Not Applicable

Kidney Cancer DNA Registry

Memorial Sloan Kettering Cancer Center14 sites in 1 country750 target enrollmentStarted: March 1, 2014Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
750
Locations
14
Primary Endpoint
establish a kidney cancer registry

Overview

Brief Summary

This registry will help us develop better methods of:

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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

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

Arms & Interventions

high risk

Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation

Intervention: salvia for germline DNA (Other)

high risk

Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation

Intervention: Family History Questionnaire (when applicable) (Behavioral)

high risk

Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation

Intervention: Blood draw (Other)

high risk

Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation

Intervention: Epidemiologic Questionnaire (Behavioral)

kidney cancer patients receiving care at MSKCC

Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire and complete the Epidemiologic Questionnaire (when applicable,), and providing a blood sample and 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.

Intervention: Blood draw (Other)

kidney cancer patients receiving care at MSKCC

Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire and complete the Epidemiologic Questionnaire (when applicable,), and providing a blood sample and 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.

Intervention: salvia for germline DNA (Other)

kidney cancer patients receiving care at MSKCC

Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire and complete the Epidemiologic Questionnaire (when applicable,), and providing a blood sample and 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.

Intervention: the Kidney Cancer Questionnaire (Behavioral)

kidney cancer patients receiving care at MSKCC

Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire and complete the Epidemiologic Questionnaire (when applicable,), and providing a blood sample and 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.

Intervention: Family History Questionnaire (when applicable) (Behavioral)

kidney cancer patients receiving care at MSKCC

Participation will consist of completing the Kidney Cancer Questionnaire Family History Questionnaire and complete the Epidemiologic Questionnaire (when applicable,), and providing a blood sample and 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.

Intervention: Epidemiologic Questionnaire (Behavioral)

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.

Intervention: salvia for germline DNA (Other)

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.

Intervention: the Kidney Cancer Questionnaire (Behavioral)

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.

Intervention: Family History Questionnaire (when applicable) (Behavioral)

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.

Intervention: salvia for germline DNA (Other)

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.

Intervention: the Kidney Cancer Questionnaire (Behavioral)

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.

Intervention: Family History Questionnaire (when applicable) (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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