We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Kidney Cancer DNA Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02087852
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Renal Cancer Other: salvia for germline DNA Behavioral: the Kidney Cancer Questionnaire Behavioral: Family History Questionnaire (when applicable) Other: Blood draw Behavioral: Epidemiologic Questionnaire

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Kidney Cancer DNA Registry
Study Start Date : March 2014
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

saliva specimen

blood

tissue (when available)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087852


Contacts
Layout table for location contacts
Contact: Jonathan Coleman, MD 646-422-4432
Contact: Kenneth Offit, MD 646-888-4050

Locations
Layout table for location information
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge (Consent and Follow-up) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Jonathan Coleman, MD    646-422-4432      
Memoral Sloan Kettering Monmouth (Consent and Follow up) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Jonathan Coleman, MD    646-422-4432      
Memorial Sloan Kettering Bergen (Consent and Follow up ) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Jonathan Coleman, MD    646-422-4432      
United States, New York
Memorial Sloan Kettering Commack (Consent and Follow-up) Recruiting
Commack, New York, United States, 11725
Contact: Jonathan Coleman, MD    646-422-4432      
Memorial Sloan Kettering Westchester (Consent and Follow up) Recruiting
Harrison, New York, United States, 10604
Contact: Jonathan Coleman, MD    646-422-4432      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Jonathan Coleman, MD    646-422-4432      
Contact: Kenneth Offit, MD    646-888-4050      
Principal Investigator: Jonathan Coleman, MD         
Memorial Sloan Kettering Nassau (Consent and Follow-Up) Recruiting
Uniondale, New York, United States, 11553
Contact: Jonathan Coleman, MD    646-422-4432      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Jonathan, MD Memorial Sloan Kettering Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02087852    
Other Study ID Numbers: 13-218
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Questionnaire
DNA
saliva
 kidney cancer
13-218
high risk
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Diseases
Adenocarcinoma
Carcinoma