Kidney Cancer DNA Registry

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02087852
Collaborator
(none)
750
7
108
107.1
1

Study Details

Study Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
750 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Kidney Cancer DNA Registry
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Behavioral: 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.

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
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.

Behavioral: 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.

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
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.

Behavioral: 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.

high risk

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

Other: salvia for germline DNA

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

  • 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

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering at Basking Ridge (Consent and Follow-up) Basking Ridge New Jersey United States 07920
2 Memoral Sloan Kettering Monmouth (Consent and Follow up) Middletown New Jersey United States 07748
3 Memorial Sloan Kettering Bergen (Consent and Follow up ) Montvale New Jersey United States 07645
4 Memorial Sloan Kettering Commack (Consent and Follow-up) Commack New York United States 11725
5 Memorial Sloan Kettering Westchester (Consent and Follow up) Harrison New York United States 10604
6 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065
7 Memorial Sloan Kettering Nassau (Consent and Follow-Up) Uniondale New York United States 11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jonathan Jonathan, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02087852
Other Study ID Numbers:
  • 13-218
First Posted:
Mar 14, 2014
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022