Clinical trial NCT04280640: Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes
Official title: LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Metastasis Lung
Metastasis to Liver
Circulating Tumor Cell
Gastrointestinal Cancer
Bladder Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with liver and/or lung metastasis who will receive systemic treatment.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between treatment response in CTCs and in vivo
timeFrame: Initiation of trial to 24 months post-initiation
Secondary outcomes:
measure: Sensitivity, specificity, and predictive values of CTC cultures' treatment response
timeFrame: Initiation of trial to 24 months post-initiation
Other outcomes:
Locations:
Study officials:
affiliation: UNC Chapel Hill
name: Andrew Z Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: