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A Multicenter Cancer Biospecimen Collection Study

ConditionsCancer of Head and NeckLung Cancer, Nonsmall CellSmall-cell Lung CancerUrothelial CarcinomaGastroesophageal Junction AdenocarcinomaCervical CancerEsophageal Squamous Cell CarcinomaTriple Negative Breast CancerHepatocellular CarcinomaRenal Cell CarcinomaColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCofactor Genomics, Inc.

About this trial

This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

head and neck squamous cell carcinoma (HNSCC)

non-small-cell lung cancer (NSCLC)

small cell lung cancer (SCLC)

urothelial carcinoma (UCC)

Disqualifiers

Inability or unwillingness to provide informed consent.

Subject who does/did not have one of the cancers listed above (other histologies).

Subject has already participated in this trial.

Trial population

Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • OncoPrism™ assay

    Diagnostic test

    OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Treatment groups

1,650 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: head and neck squamous cell carcinoma (HNSCC)1 intervention
Group B: non-small-cell lung cancer (NSCLC)1 intervention
Group C: small cell lung cancer (SCLC)1 intervention
Group D: urothelial carcinoma (UCC)1 intervention
Group E: gastric or gastroesophageal junction adenocarcinoma1 intervention
Group F: cervical cancer1 intervention
Group G: esophageal squamous cell carcinoma (ESCC)1 intervention
Group H: triple-negative breast cancer (TNBC)1 intervention
Group I: hepatocellular carcinoma (HCC)1 intervention
Group J: renal cell carcinoma (RCC)1 intervention
Group K: colorectal cancer (CRC)1 intervention

Trial outcomes

Primary outcomes

1

PD-L1/PD-1 inhibitor response

No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cofactor Genomics, Inc.

Lead sponsor

Curebase Inc.

Collaborator

Source ClinicalTrials.gov
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