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PRospective rEgistry OF Advanced Stage cancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine (PREFER)

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ClinicalTrials.gov Identifier: NCT05697198
Recruitment Status : Recruiting
First Posted : January 25, 2023
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Labcorp Drug Development Inc

Brief Summary:

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).


Condition or disease Intervention/treatment
Lung Cancer Ovarian Cancer Uterine Cancer Colorectal Cancer Stomach Cancer Esophageal Cancer Pancreatic Cancer Melanoma Breast Cancer Head and Neck Cancer Soft Tissue Sarcoma Rhabdomyosarcoma Prostate Cancer Diagnostic Test: OmniSeq Test

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: 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
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023


Group/Cohort Intervention/treatment
Cohort lung cancer Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Gyn malignancies Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Gastrointestinal malignancies Cohort Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Melanoma Cohort Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Breast cancer Cohort Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Head and neck cancer Cohort Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Sarcoma and soft tissue cancer cohort Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors

Prostate cancer Diagnostic Test: OmniSeq Test
Genomic and immune profiling assay for all solid tumors




Primary Outcome Measures :
  1. The percent adoption of the OmniSeq next generation sequencing (NGS) testing platform in an advanced cancer patient population compared to baseline over a 2 year period [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with advanced solid tumors
Criteria

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.

Exclusion Criteria

  • Subjects incapable of understanding the items listed in the ICF and the consent process
  • Pregnant females
  • Subjects with a history of or known psychiatric illness that deems them unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05697198


Contacts
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Contact: Dhwani Mehta 551-998-3385 dmehta@cbcca.net

Locations
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United States, Alabama
Clinical Site Recruiting
Fort Payne, Alabama, United States, 35958
United States, Florida
Clinical Site Recruiting
Orange City, Florida, United States, 32763
Clinical Site Recruiting
Stuart, Florida, United States, 34994
United States, Georgia
Clinical Site Recruiting
Dublin, Georgia, United States, 31021
United States, Indiana
Clinical Site Recruiting
Fort Wayne, Indiana, United States, 46804
United States, Louisiana
Clinical Site Recruiting
Covington, Louisiana, United States, 70433
United States, North Carolina
Clinical Site Recruiting
Huntersville, North Carolina, United States, 28078
United States, South Carolina
Clinical Site Recruiting
Rock Hill, South Carolina, United States, 29732
Sponsors and Collaborators
Labcorp Drug Development Inc
Additional Information:
Publications:
Tutton R. Biobanks and the inclusion of racial/ethnic minorities. Race/ Ethnicity: Multidisciplinary Global Contexts; 2009. p. 75-95.

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Responsible Party: Labcorp Drug Development Inc
ClinicalTrials.gov Identifier: NCT05697198    
Other Study ID Numbers: PREFER
First Posted: January 25, 2023    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Rhabdomyosarcoma
Sarcoma
Stomach Neoplasms
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Histologic Type
Genital Neoplasms, Female
Neoplasms, Connective and Soft Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Stomach Diseases
Uterine Diseases