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Enrolling by invitation NCT02555735

Exceptional Responders With Solid Tumor Cancer to Chemotherapy

— Observational Solid Tumor Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care Chemotherapy.
Who it may be relevant to
Registry conditions: Solid Tumor Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Exceptional Responders With Solid Tumor Cancer

Overview

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

  • Drug Standard of Care Chemotherapy
    Physician's Choice Chemotherapy Treatment (non-guided)

Primary outcome measures

  • Identify exceptional responders with cancer to standard of care chemotherapy [Time frame: 9 years]
Secondary outcome measures (1)
  • Correlation of genomic profiles from circulating cells with overall survival [Time frame: 9 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The Pancreatic Cancer Treatment Center of Los Angeles — Los Angeles

Publications

  • Yu KH, Ricigliano M, McCarthy B, Chou JF, Capanu M, Cooper B, Bartlett A, Covington C, Lowery MA, O'Reilly EM. Circulating Tumor and Invasive Cell Gene Expression Profile Predicts Treatment Response and Survival in Pancreatic Adenocarcinoma. Cancers (Basel). 2018 Nov 24;10(12):467. doi: 10.3390/cancers10120467. PMID 30477242
  • Isacoff WH, Cooper B, Bartlett A, McCarthy B, Yu KH. ChemoSensitivity Assay Guided Metronomic Chemotherapy Is Safe and Effective for Treating Advanced Pancreatic Cancer. Cancers (Basel). 2022 Jun 13;14(12):2906. doi: 10.3390/cancers14122906. PMID 35740571
  • Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1. PMID 35647938

Identifiers

NCT: NCT02555735 · ADRL-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗