Unified Network for Integrated Fluid Collection at Yale (UNIFY)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Molecular Residual Disease

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Mitchell Elliott, MD; Phone Number: 475-375-7981; Email: Mitchell.elliott@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Smilow Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish a repository	Establish a repository of clinically annotated liquid biopsy biospecimens (and optional archival tumor specimens) for current and future research.	Through study completion, up to 5 years
Collection of blood for additional methods	Facilitate the collection of blood for additional methods of scientific analysis in parallel with cfNA analysis.	Through study completion, up to 5 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Maryam Lustberg, MD, MPH, Yale University; Principal Investigator: Mitchell Elliott, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Liquid Biopsy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2000042786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No