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

LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Bladder Cancer; Gastrointestinal Cancer; Circulating Tumor Cell; Metastasis Lung; Metastasis to Liver
• Intervention / Treatment: Other: Blood Draw

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with liver and/or lung metastasis who will receive systemic treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metastatic Cancer Pts Receiving Molecularly Targeted Therapy; Metastatic cancer patients (with liver and/or lung metastasis) who will receive molecularly targeted therapy based on genomic testing data	Other: Blood Draw; A blood sample will be collected once, prior to treatment.
GI Cancer Pts; Gastrointestinal cancer patients (with liver and/or lung metastasis) who will receive 3rd line treatments or enrolled on a targeted therapy treatment trial	Other: Blood Draw; A blood sample will be collected once, prior to treatment.
Bladder Cancer Pts; Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment	Other: Blood Draw; A blood sample will be collected once, prior to treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between treatment response in CTCs and in vivo	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)	Initiation of trial to 24 months post-initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity, and predictive values of CTC cultures' treatment response	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)	Initiation of trial to 24 months post-initiation

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Andrew Z Wang, MD, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplastic Processes; Neoplasm Metastasis; Gastrointestinal Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: LCCC1938

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No