Prospective Study to Assess a Diagnostic Aid for Cancer

Conditions

• Cancer

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Blood sample collection — OTHER
  The study will collect up to 40 mL of whole peripheral blood in Streck Cell-Free DNA BCT® tubes from each participant.

Study Details

The primary objective of this study is to establish the performance of two blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings suggestive of cancer.

Key Dates

Start date

Jul 11, 2025

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

1,650 participants (estimated)

Arms

• Arm: Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer
  Individuals 45 years of age or older who have signs, symptoms, and/or findings that their doctor suspects may be related to cancer, or who have recently been diagnosed with cancer and have not received treatment for this cancer.

Primary Outcome Measure

Performance of two diagnostic aid tests among individuals presenting with symptoms, signs and/or clinical findings suggestive of one or more cancers originating from the protocol-specified sites: a multi-cancer (MC) and gastrointestinal-focused (GI) test [ Time Frame: 18 months ]

Central Contacts

• Sara Bardwell
  (617) 446-9266
  [email protected]
• Nate Ruffle-Deignan
  [email protected]

Locations (39)

Find similar trials in Coronado, CA

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