Exceptional Responders With Solid Tumor Cancer to Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Exceptional Responders With Solid Tumor Cancer

Conditions
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Solid Tumor Neoplasms

Intervention / Treatment
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* Drug: Standard of Care Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solid Tumor Cancer<br>Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy. | Drug: Standard of Care Chemotherapy<br>* Physician's Choice Chemotherapy Treatment (non-guided)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify exceptional responders with cancer to standard of care chemotherapy | Identify responders and non-responders | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of genomic profiles from circulating cells with overall survival | Genomic expression profiles correlated with progression free and overall survival | 9 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumor cancer