Clinical trial NCT02555735: Exceptional Responders With Solid Tumor Cancer to Chemotherapy
Official title: Evaluation of Exceptional Responders With Solid Tumor Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Solid Tumor Neoplasms
Keywords: Solid Tumor cancer
Lead sponsor: Adera Labs, LLC
Sponsor class: INDUSTRY
Collaborators: name: The Pancreatic Cancer Treatment Center of Los Angeles
First posted: 2015-09-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with solid tumor cancers

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.

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

Primary outcomes:
measure: Identify exceptional responders with cancer to standard of care chemotherapy
timeFrame: 9 years
Secondary outcomes:
measure: Correlation of genomic profiles from circulating cells with overall survival
timeFrame: 9 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Pancreatic Cancer Treatment Center of Los Angeles
state: California
Study officials:
affiliation: Adera Labs
name: Brian McCarthy, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.