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Exceptional Responders With Solid Tumor Cancer to Chemotherapy

Evaluation of Exceptional Responders With Solid Tumor Cancer

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02555735
Enrollment
250
Registered
2015-09-22
Start date
2015-10-31
Completion date
2027-08-31
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor Neoplasms

Keywords

Solid Tumor cancer

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.

Interventions

Physician's Choice Chemotherapy Treatment (non-guided)

Sponsors

The Pancreatic Cancer Treatment Center of Los Angeles
CollaboratorUNKNOWN
Adera Labs, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identify exceptional responders with cancer to standard of care chemotherapy9 yearsIdentify responders and non-responders

Secondary

MeasureTime frameDescription
Correlation of genomic profiles from circulating cells with overall survival9 yearsGenomic expression profiles correlated with progression free and overall survival

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026