RECRUITING

Prospective Study to Assess a Diagnostic Aid for Cancer

Conditions

Cancer Diagnostic Oncology Test Observational

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the performance of a blood-based diagnostic aid test for cancer detection in individuals presenting with symptoms, signs, or findings that raise clinical suspicion for cancer.

Official Title

Prospective Cohort Study With Case Enrichment to Assess a Diagnostic Aid for Cancer in Symptomatic Subjects (PROCARES)

Quick Facts

Study Start:2025-07-08

Study Completion:2027-05-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07046260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects aged ≥45 years at the time of informed consent 2. Provided written or electronic informed consent, according to local guidelines, signed and dated by the Subject or by a legal guardian prior to the performance of any study- specific procedures, sampling, or analyses 3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND 1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR 2. have a confirmed diagnosis of cancer, determined within 45 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment.	1. History of any prior invasive or hematological malignancy (Individuals with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted) 2. Subject is suffering from any febrile illness defined as a temperature \>101.5°F within the last 48 hours 3. Subject is pregnant (Self-reported) 4. Subject is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject with a corneal transplant can be considered for study entry) 5. Inability or unwillingness to comply with study procedures or follow-up requirement 6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health 7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes 8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study

Inclusion Criteria

Exclusion Criteria

1. Subjects aged ≥45 years at the time of informed consent
2. Provided written or electronic informed consent, according to local guidelines, signed and dated by the Subject or by a legal guardian prior to the performance of any study- specific procedures, sampling, or analyses
3. Presentation with symptoms, signs, and/or findings that raise clinical suspicion of one or more of the protocol-specified sites AND
1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR
2. have a confirmed diagnosis of cancer, determined within 45 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment.

1. History of any prior invasive or hematological malignancy (Individuals with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted)
2. Subject is suffering from any febrile illness defined as a temperature \>101.5°F within the last 48 hours
3. Subject is pregnant (Self-reported)
4. Subject is a recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Subject with a corneal transplant can be considered for study entry)
5. Inability or unwillingness to comply with study procedures or follow-up requirement
6. Previous or current participation in any study sponsored by, or employment with, Harbinger Health
7. Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study

Contacts and Locations

Study Contact

Sara Bardwell

CONTACT

(617) 446-9266

sbardwell@harbinger-health.com

Nate Ruffle-Deignan

CONTACT

nrdeignan@harbinger-health.com

Principal Investigator

Luke Pike, MD, DPhil

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Christie Clinic

Champaign, Illinois, 61820

United States

Susquehanna Research Group

Harrisburg, Pennsylvania, 17110

United States

Activian Clinical Research

Kingwood, Texas, 77339

United States

Collaborators and Investigators

Sponsor: Harbinger Health

Luke Pike, MD, DPhil, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-08

Study Completion Date2027-05-25

Study Record Updates

Study Start Date2025-07-08

Study Completion Date2027-05-25

Terms related to this study

Keywords Provided by Researchers

Cancer
Diagnostic
Oncology
Test
Observational

Additional Relevant MeSH Terms

Cancer