Unified Network for Integrated Fluid Collection at Yale
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,500 Participants
are grouped into 2 trial groupsGroup A: UNIFY
Group B: UNIFY plus
Trial outcomes
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 yearsSecondary 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 years2
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov