Kidney Cancer DNA Registry

Study Overview
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Brief Summary
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This registry will help us develop better methods of: Preventing these cancers Diagnosing these cancers Treating these cancers

Official Title
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Kidney Cancer DNA Registry

Conditions
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Renal Cancer

Intervention / Treatment
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* Other: salvia for germline DNA
* Behavioral: the Kidney Cancer Questionnaire
* Behavioral: Family History Questionnaire (when applicable)
* Other: Blood draw
* Behavioral: Epidemiologic Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| kidney cancer patients receiving care at MSKCC<br>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<br> <br> Behavioral: the Kidney Cancer Questionnaire<br>* 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.<br>Behavioral: Family History Questionnaire (when applicable)<br>* 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.<br>Other: Blood draw<br> <br> Behavioral: Epidemiologic Questionnaire<br>* 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.<br>|
| relatives of patients with kidney cancer<br>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<br> <br> Behavioral: the Kidney Cancer Questionnaire<br>* 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.<br>Behavioral: Family History Questionnaire (when applicable)<br>* 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.<br>|
| healthy controls who are unrelated & do not have hx of cancer<br>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<br> <br> Behavioral: the Kidney Cancer Questionnaire<br>* 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.<br>Behavioral: Family History Questionnaire (when applicable)<br>* 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.<br>|
| high risk<br>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<br> <br> Behavioral: Family History Questionnaire (when applicable)<br>* 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.<br>Other: Blood draw<br> <br> Behavioral: Epidemiologic Questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney cancer, Questionnaire, DNA, saliva, 13-218, high risk