NCT02087852

Brief Summary

This registry will help us develop better methods of:

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2014Mar 2027

Study Start

First participant enrolled

March 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

13 years

First QC Date

March 12, 2014

Last Update Submit

April 6, 2026

Conditions

Keywords

QuestionnaireDNAsalivakidney cancer13-218high risk

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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 DNABehavioral: the Kidney Cancer QuestionnaireBehavioral: Family History Questionnaire (when applicable)Other: Blood drawBehavioral: Epidemiologic Questionnaire

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 DNABehavioral: the Kidney Cancer QuestionnaireBehavioral: 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 DNABehavioral: the Kidney Cancer QuestionnaireBehavioral: Family History Questionnaire (when applicable)

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 DNABehavioral: Family History Questionnaire (when applicable)Other: Blood drawBehavioral: Epidemiologic Questionnaire

Interventions

healthy controls who are unrelated & do not have hx of cancerhigh riskkidney cancer patients receiving care at MSKCCrelatives of patients with kidney cancer

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 cancerkidney cancer patients receiving care at MSKCCrelatives of patients with kidney cancer
high riskkidney cancer patients receiving care at MSKCC

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 riskkidney cancer patients receiving care at MSKCC

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 cancerhigh riskkidney cancer patients receiving care at MSKCCrelatives of patients with kidney cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Consent and Follow-up)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent and Follow up)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent and Follow up )

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack (Consent and Follow-up)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent and Follow up)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent and Follow-Up)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

saliva specimen blood tissue (when available)

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jonathan Jonathan, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Coleman, MD

CONTACT

Kenneth Offit, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations