Exceptional Responders With Solid Tumor Cancer to Chemotherapy

NCT02555735 | Enrolling By Invitation

• 1 other identifier: ADRL-003
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor Neoplasms

Keywords

Solid Tumor cancer

Outcome Measures

Primary Outcomes (1)

• Identify exceptional responders with cancer to standard of care chemotherapy

  Identify responders and non-responders

  9 years

Secondary Outcomes (1)

• Correlation of genomic profiles from circulating cells with overall survival

  9 years

Study Arms (1)

Solid Tumor Cancer

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

Drug: Standard of Care Chemotherapy

Interventions

Standard of Care Chemotherapy DRUG

Physician's Choice Chemotherapy Treatment (non-guided)

Solid Tumor Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with solid tumor cancers

You may qualify if:

• Histological or cytological confirmation of solid tumor carcinoma.
• Patient is treatment-naïve or currently receiving chemotherapy.
• ECOG performance status (any).

You may not qualify if:

• 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

Sponsors & Collaborators

• Adera Labs, LLC: lead
• The Pancreatic Cancer Treatment Center of Los Angeles: collaborator

Study Sites (1)

The Pancreatic Cancer Treatment Center of Los Angeles

Los Angeles, California, 90024, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Brian McCarthy, PhD

  Adera Labs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)