NCT05697198Completed
PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine
PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations Using the OmniSeq Test and Creation of a Biobank from Community Cancer Clinics in the United States to Address Disparities in Precision Medicine
Source: ClinicalTrials.gov · Last updated 6 Mar 2025
Brief summary (registry, in English)
The objective of this Study is to collect, process, and transfer biologic samples such as blood and/or tissue biopsies to determine the concordance of detected alterations obtained through liquid biopsy analyses compared to next generation sequencing of time-matched or archival tissue specimens from individuals with advanced solid tumors. Examples of locally advanced and metastatic tumors include stage III and IV cancers (ex. lung, breast, all gastrointestinal malignancies, all gynecologic malignancies, prostate cancer, head and neck tumors, soft tissue cancers, and melanoma). These specimens will be analyzed for diagnostic purposes and research (either by Labcorp/OmniSeq or to a third-party recipient designated by Labcorp/OmniSeq). Labcorp/OmniSeq may transfer the specimens and data to its clients, including commercial, academic or non-profit research institutions; or alternatively, may retain the specimens in its repository for future research use at the sole discretion of Labcorp/OmniSeq and or assignees. Labcorp/OmniSeq will maintain all detailed clinical information including demographic data (de-identified), ethnicity, disease state, stage (radiological, pathological and clinical-whichever is relevant).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1429 (actual)
- First submitted
- 21 Dec 2022
- Start date
- 19 Apr 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Labcorp Corporation of America Holdings, Inc
- Diseases
- Prostate cancer, Head and neck cancer, Melanoma, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer, Sarcoma
- NCT number
- NCT05697198
What you commit to
- Study type: Observational
- Participants enrolled: 1429
- From 19 Apr 2021 to the primary completion date, 31 Dec 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with a history of or known psychiatric illness that deems them unable to consent
Other
- Subjects incapable of understanding the items listed in the ICF and the consent process
- Pregnant females
Criteria the registry did not label
- Case Inclusion Criteria
- Any gender, race, or ethnicity is acceptable
- Must be at least 18 years of age
- All subjects must fall into the following group:
- All Cases will be classified as following cohorts
- Cohort lung cancer - Subject must meet the following criteria:
- Recently diagnosed advanced lung cancer
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable) and/or on treatment
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Gyn malignancies (list ovarian and uterine cancer separately)
- Recently diagnosed advanced gynecological malignancies
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Gastrointestinal malignancies Cohort (list all cancers separately-colorectal, gastric, esophageal and pancreatic)
- Recently diagnosed advanced gastrointestinal malignancy
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Melanoma Cohort
- Recently diagnosed advanced melanoma
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Breast cancer Cohort
- Recently diagnosed advanced breast cancer
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Head and neck cancer Cohort
- Recently diagnosed advanced head and neck cancer
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Sarcoma and soft tissue cancer cohort
- Recently diagnosed advanced cancer
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Prostate cancer
- Recently diagnosed advanced cancer
- Locally advanced and metastatic solid tumors
- Treatment naïve (not yet treated or tumor removed; biopsy acceptable).
- Previously Treated: If treated, must have developed resistance and testing will be looking at change in therapy based on results of testing
- Additional Requirements
- Subjects must be diagnosed by appropriate histopathology
- Subjects can have any concurrent diseases
- Must voluntarily sign and understand the most current Institutional Review Board/Independent Ethics Committee (IRB/IEC) - approved Informed Consent Form (ICF) prior to study participation. Witness must sign the informed consent form if the subject is illiterate.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Site Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Dublin | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Fort Payne | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rock Hill | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.