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RecruitingNCT07689864UNIFYUpdated Aug 25, 2026

Unified Network for Integrated Fluid Collection at Yale

An observational study in Molecular Residual Disease and Cancer, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Yale University · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Molecular Residual Disease
  • Cancer

Browse trials for

Keywords

  • Liquid Biopsy
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 205 across 1,680 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: Through study completion, up to 5 years

Secondary outcomes

  1. Establish a repository

    Establish a repository of clinically annotated liquid biopsy biospecimens (and optional archival tumor specimens) for current and future research.

    Time frame: Through study completion, up to 5 years

  2. Collection of blood for additional methods

    Facilitate the collection of blood for additional methods of scientific analysis in parallel with cfNA analysis.

    Time frame: Through study completion, up to 5 years

07

Study locations

1 of 1 sites recruiting
  • Smilow Cancer Hospital
    New Haven, Connecticut 06519, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07689864
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Jul 8, 2026
Start date
Aug 25, 2026
Primary completion
Aug 2031 (estimated)
Completion
Aug 2031 (estimated)
Last update
Aug 25, 2026

Study contacts

Mitchell Elliott, MD
Contact
Mitchell.elliott@yale.edu
475-375-7981
Mitchell Elliott, MD
principal investigator · Yale University
Maryam Lustberg, MD, MPH
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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