Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-12-31
2027-12-31
Brief Summary
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Detailed Description
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Participants will consent to the acquisition and analysis of prospective tissue specimens collected at relevant treatment time points (e.g., pre-treatment, response, primary or acquired resistance, and/or at the occurrence of toxicity), based on their cancer treatment course, whether routine care or as part of another clinical trial. Prospective tissue collection include fresh tissue collection at the time of procedures that are conducted at YNHH as part of standard of care (SOC) or clinical trial protocols (procedures billed to either insurance or trial sponsor). Tissue in excess of what is required for diagnostic/clinical uses will be used for research. If an adult participant consents, draining and regional lymph nodes may be obtained for research purposes.
In addition, 20 mL of blood may be collected at time of surgery for correlative biomarker studies and the extraction of germline DNA.
Eligible patients will be identified and consented by their treating clinician (PI or sub- investigators) and/or designated research staff.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Specimen collection
This single arm study will assess adult patients with either a known or suspected kidney cancer referred to Yale Genitourinary Oncology providers in the Yale Urology, Medical Oncology, Radiation Oncology, or Nephrology Departments. Specimens collected will include peripheral blood sample for immune analysis, tumor sample for analysis, adjacent non-malignant kidney for analysis, draining lymph nodes for analysis and finally, regional non-draining lymph nodes for analysis.
Peripheral Blood Sample for Immune Analysis
A peripheral blood sample will be collected at the time of surgery.
Tumor Sample for Analysis
Extra tumor which is left over following clinical diagnoses will be collected.
Adjacent non-malignant kidney for analysis
Extra normal tissue which is left over following clinical diagnoses will be collected.
Draining lymph node(s) for analysis
Draining lymph nodes which have been identified by the surgeon visually, potentially using a tracer (injection of up to 5mg of ICG into the peritumor kidney) will be collected.
Regional non-draining lymph node(s) for analysis
Regional lymph nodes which have been deemed as non-draining by the surgeon will be collected.
Interventions
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Peripheral Blood Sample for Immune Analysis
A peripheral blood sample will be collected at the time of surgery.
Tumor Sample for Analysis
Extra tumor which is left over following clinical diagnoses will be collected.
Adjacent non-malignant kidney for analysis
Extra normal tissue which is left over following clinical diagnoses will be collected.
Draining lymph node(s) for analysis
Draining lymph nodes which have been identified by the surgeon visually, potentially using a tracer (injection of up to 5mg of ICG into the peritumor kidney) will be collected.
Regional non-draining lymph node(s) for analysis
Regional lymph nodes which have been deemed as non-draining by the surgeon will be collected.
Eligibility Criteria
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Inclusion Criteria
Participant eligibility will be determined by study investigators and will be offered protocol details. Interested participants will be invited to participate by study investigators. Consent will be obtained by study investigators or other authorized study personnel. Any potential adult participants with known or suspected kidney cancers with a renal mass who are patients of non-study physicians will be invited to participate by study personal only with the approval of their treating physician.
Exclusion Criteria
* Participants known to be pregnant or actively breastfeeding.
* Iodine allergy hypersensitivity.
18 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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David Braun, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000039529
Identifier Type: -
Identifier Source: org_study_id