Unified Network for Integrated Fluid Collection at Yale

NCT07689864 | Not Yet Recruiting

• 1 other identifier: 2000042786
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

UNIFY is a Yale-wide liquid biopsy master repository that prospectively collects Streck-tube blood, dried blood spots (and optional archival tissue) from Yale Cancer Center patients across all tumor types for current and future research.

Conditions

Molecular Residual Disease; Cancer

Keywords

Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• Collection and annotation of biospecimens

  Facilitate and streamline the collection, banking, and clinical annotation of liquid biopsy biospecimens (peripheral blood collected in Streck Cell-Free DNA BCT® tubes or blood spots) - and, optionally, corresponding archival tumor specimens - for cancer research studies across Yale Cancer Center and the Smilow Cancer Hospital network.

  Through study completion, up to 5 years

Secondary Outcomes (2)

• Establish a repository

  Through study completion, up to 5 years

• Collection of blood for additional methods

  Through study completion, up to 5 years

Study Arms (2)

UNIFY

Patients enrolled in UNIFY only, with biological samples and limited clinical data collected as stipulated by this protocol

UNIFY plus

UNIFY plus a co-enrolled primary research study: Patients concurrently enrolled in a separate IRB-approved under UNIFY, limited clinical data will be collected for this cohort under the primary research study that requires blood sampling and optional or mandatory tumor tissue collection for research purposes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNIFY will enroll Yale Cancer Center patients with histologically or radiologically suspected or confirmed solid tumor or hematologic malignancy of any type or stage, as well as individuals identified as high-risk for cancer.

You may qualify if:

• Histological or radiological evidence of a suspected or confirmed solid tumor or hematologic malignancy, OR an individual identified as high-risk for cancer (based on identified germline aberration in a cancer predisposition gene, hormonal or medical risk factors, and/or significant family history of malignancy).
• Willing and able to provide informed consent and HIPAA authorization for participation in UNIFY.
• If being co-consented for a separate primary research study, the participant must also fulfill the eligibility criteria for that primary research study. Where there is a discrepancy in eligibility criteria between UNIFY and the primary research study, the primary research study's criteria take precedence.

You may not qualify if:

• Inability to provide informed consent.
• Any medical contraindication to peripheral venipuncture as judged by the treating physician or research team (e.g., severe coagulopathy or other contraindication to additional research blood draw).

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Smilow Cancer Hospital

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples collected serially for DNA extraction, dried blood spots, archived tissue samples.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mitchell Elliott, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Maryam Lustberg, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Elliott, MD

CONTACT

475-375-7981; Mitchell.elliott@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)