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 : May 12, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 2021 |
Estimated Study Completion Date : | March 2021 |

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. |
- 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)

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.
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 |
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

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
Contact: Jonathan Coleman, MD | 646-422-4432 | ||
Contact: Kenneth Offit, MD | 646-888-4050 |
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 |
Principal Investigator: | Jonathan Jonathan, MD | Memorial Sloan Kettering Cancer Center |
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: | May 12, 2020 |
Last Verified: | May 2020 |
Questionnaire DNA saliva |
kidney cancer 13-218 high risk |
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 |