Unified Network for Integrated Fluid Collection at Yale

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07689864

Acronym

UNIFY

Enrollment

2500

Registered

2026-07-08

Start date

2026-08-25

Completion date

2031-08-01

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Molecular Residual Disease

Keywords

Liquid Biopsy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Collection and annotation of biospecimens	Through study completion, up to 5 years	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.

Secondary

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

Countries

United States

Contacts

CONTACTMitchell Elliott, MD

Mitchell.elliott@yale.edu475-375-7981

PRINCIPAL_INVESTIGATORMitchell Elliott, MD

Yale University

PRINCIPAL_INVESTIGATORMaryam Lustberg, MD, MPH