Kidney Cancer DNA Registry

Recruiting

• Conditions: Renal Cancer
• Interventions: Other: salvia for germline DNA; Behavioral: the Kidney Cancer Questionnaire; Behavioral: Family History Questionnaire (when applicable); Other: Blood draw; Behavioral: Epidemiologic Questionnaire

• Registration Number: NCT02087852
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls who are unrelated & do not have hx of cancer	Family History Questionnaire (when applicable)	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.
relatives of patients with kidney cancer	the Kidney Cancer Questionnaire	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.
healthy controls who are unrelated & do not have hx of cancer	the Kidney Cancer Questionnaire	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.
kidney cancer patients receiving care at MSKCC	salvia for germline DNA	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.
kidney cancer patients receiving care at MSKCC	Family History Questionnaire (when applicable)	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.
kidney cancer patients receiving care at MSKCC	the Kidney Cancer Questionnaire	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.
kidney cancer patients receiving care at MSKCC	Blood draw	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.
kidney cancer patients receiving care at MSKCC	Epidemiologic Questionnaire	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.
high risk	salvia for germline DNA	Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation
high risk	Family History Questionnaire (when applicable)	Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation
relatives of patients with kidney cancer	salvia for germline DNA	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.
healthy controls who are unrelated & do not have hx of cancer	salvia for germline DNA	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.
high risk	Blood draw	Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation
high risk	Epidemiologic Questionnaire	Participation will consist of completing the Epidemiologic Questionnaire, Family History Questionnaire (if + FH), provide saliva and blood sample , referral for screening evaluation
relatives of patients with kidney cancer	Family History Questionnaire (when applicable)	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.

Primary Outcome Measures

Name	Time	Method
establish a kidney cancer registry	5 years	with detailed epidemiologic data and germline DNA available for next generation sequencing from consenting patients, selected family members, and healthy unrelated controls.

Trial Locations

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Consent and Follow-up); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack (Consent and Follow-up); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent and Follow up); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Bergen (Consent and Follow up ); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent and Follow up); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Nassau (Consent and Follow-Up); 🇺🇸 Uniondale, New York, United States