NCT04280640

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cancer
• Metastasis Lung
• Metastasis to Liver
• Circulating Tumor Cell
• Gastrointestinal Cancer
• Bladder Cancer

Interventions

Type	Name	Description
OTHER	Blood Draw	A blood sample will be collected once, prior to treatment.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-02-21
• Last updated: 2021-10-18