Molecular Residual DiseaseUNIFYNCT07689864
Unified Network for Integrated Fluid Collection at Yale
An observational study of Molecular Residual Disease and Cancer, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Molecular Residual Disease, Cancer
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Smilow Cancer Hospital
New Haven, Connecticut, 06519
About this study
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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 5 years
Secondary outcomes (2)
Establish a repository
Establish a repository of clinically annotated liquid biopsy biospecimens (and optional archival tumor specimens) for current and future research.
Measured: 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.
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start25 Aug 2026
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular Residual DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Elliott, MD, Principal investigator, Yale UniversityMaryam Lustberg, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689864
- Sponsor's protocol ID
- 2000042786
- Acronym
- UNIFY
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Network for Integrated Fluid Collection at Yale
- ClinicalTrials.gov ID
- NCT07689864
- Acronym / sponsor ID
- UNIFY / 2000042786
- Conditions
- Molecular Residual Disease, Cancer
- Keywords
- Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection and annotation of biospecimens
Time frame: 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.
2 secondary outcomes
Establish a repository
Time frame: Through study completion, up to 5 years
Collection of blood for additional methods
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Elliott, MD principal investigator
Yale University
Maryam Lustberg, MD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molecular Residual Disease and Cancer, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell Elliott, MD (475-375-7981, Mitchell.elliott@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection and annotation of biospecimens (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.