Exceptional Responders With Solid Tumor Cancer to Chemotherapy

• Conditions: Solid Tumor Neoplasms
• Interventions: Drug: Standard of Care Chemotherapy

• Registration Number: NCT02555735
• Lead Sponsor: Adera Labs, LLC

Brief Summary

This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

Detailed Description

This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Study Start: 2015-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2026-12
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Histological or cytological confirmation of solid tumor carcinoma.
• Patient is treatment-naïve or currently receiving chemotherapy.
• ECOG performance status (any).

Exclusion Criteria

• HIV positive on antiretroviral therapy
• Pregnant or lactating
• Prior organ allograft
• Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid Tumor Cancer	Standard of Care Chemotherapy	Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy.

Primary Outcome Measures

Name	Time	Method
Identify exceptional responders with cancer to standard of care chemotherapy	9 years	Identify responders and non-responders

Secondary Outcome Measures

Name	Time	Method
Correlation of genomic profiles from circulating cells with overall survival	9 years	Genomic expression profiles correlated with progression free and overall survival

Trial Locations

Locations (1)

The Pancreatic Cancer Treatment Center of Los Angeles; 🇺🇸 Los Angeles, California, United States