Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes

Withdrawn

• Conditions: Metastasis to Liver; Circulating Tumor Cell; Metastasis Lung; Cancer; Gastrointestinal Cancer; Bladder Cancer
• Interventions: Other: Blood Draw

• Registration Number: NCT04280640
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.

Detailed Description

This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2021-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. Patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts:

  • Patients had a tumor or liquid biopsy with molecular analysis (genomic analysis or other type of molecular characterization) resulting in a therapeutic target with planned targeted therapy by the patient's treating physician.
  • Gastric cancer patients who have failed the first and second line chemotherapy.
  • Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment.

• Scheduled to initiate systemic treatment for management of their disease. The systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy.

• ≥18 years of age

• Written informed consent obtained and signed

• Able to have blood collection without excessive difficulty

Exclusion Criteria

• Patient unwilling or unable to complete informed consent
• Currently pregnant or lactating women
• Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic Cancer Pts Receiving Molecularly Targeted Therapy	Blood Draw	Metastatic cancer patients (with liver and/or lung metastasis) who will receive molecularly targeted therapy based on genomic testing data
GI Cancer Pts	Blood Draw	Gastrointestinal cancer patients (with liver and/or lung metastasis) who will receive 3rd line treatments or enrolled on a targeted therapy treatment trial
Bladder Cancer Pts	Blood Draw	Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment

Primary Outcome Measures

Name	Time	Method
Correlation between treatment response in CTCs and in vivo	Initiation of trial to 24 months post-initiation	To estimate the agreement between CTC cultures' response to treatment, dichotomized as either yes or no response, to the clinical response in patients to treatment, dichotomized as either progressive disease (PD) versus complete response (CR), partial response (PR), or stable disease (SD)

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity, and predictive values of CTC cultures' treatment response	Initiation of trial to 24 months post-initiation	To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)