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OpenTrials
Enrolling by Invitation

NCT Number: NCT02555735

Exceptional Responders With Solid Tumor Cancer to Chemotherapy

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Pancreatic Cancer Treatment Center of Los Angeles

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care Chemotherapy

Drug

Physician's Choice Chemotherapy Treatment (non-guided)

Primary outcomes

  1. Identify exceptional responders with cancer to standard of care chemotherapy

    Time frame: 9 years

    Identify responders and non-responders

Secondary outcomes

  1. Correlation of genomic profiles from circulating cells with overall survival

    Time frame: 9 years

    Genomic expression profiles correlated with progression free and overall survival

Sponsors and collaborators

Lead sponsor

Adera Labs, LLC

Industry

Collaborators

  • The Pancreatic Cancer Treatment Center of Los Angeles

Registry information

Official study title

Evaluation of Exceptional Responders With Solid Tumor Cancer

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2015
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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