Exceptional Responders With Solid Tumor Cancer to Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2027-08-31

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.

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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.

Conditions

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Solid Tumor Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Solid Tumor Cancer

Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy.

Standard of Care Chemotherapy

Intervention Type DRUG

Physician's Choice Chemotherapy Treatment (non-guided)

Interventions

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Standard of Care Chemotherapy

Physician's Choice Chemotherapy Treatment (non-guided)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No