Kidney Cancer DNA Registry

Renal Cancer Clinical Trial

Official title:

Kidney Cancer DNA Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087852
• Other study ID #: 13-218
• Status: Recruiting
• Start date: March 2014
• Est. completion date: March 2026

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jonathan Coleman, MD
• Phone: 646-422-4432
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This registry will help us develop better methods of: - Preventing these cancers - Diagnosing these cancers - Treating these cancers

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Intervention

Other:
• salvia for germline DNA

Behavioral:
• the Kidney Cancer Questionnaire
Patients will complete the appropriate surveys on either paper or on the computer/iPad in the office using REDCap software. If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. The survey data that is collected in REDCap will be stored in REDCap. Clinic staff may also call patients to remind patients to complete questionnaires.
• Family History Questionnaire (when applicable)
Patients will complete the appropriate surveys on either paper or on the computer/iPad in the office using REDCap software. If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. The survey data that is collected in REDCap will be stored in REDCap. Clinic staff may also call patients to remind patients to complete questionnaires.

Other:
• Blood draw

Behavioral:
• Epidemiologic Questionnaire
Patients will complete the appropriate surveys on either paper or on the computer/iPad in the office using REDCap software. If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. The survey data that is collected in REDCap will be stored in REDCap. Clinic staff may also call patients to remind patients to complete questionnaires.

Locations

Country	Name	City	State
United States	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 Monmouth (Consent and Follow up)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent and Follow up )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent and Follow-Up)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish a kidney cancer registry	with detailed epidemiologic data and germline DNA available for next generation sequencing from consenting patients, selected family members, and healthy unrelated controls.	5 years

External Links

•   Memorial Sloan Kettering Cancer Center