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

NCT04280640 | Withdrawn DMC

• 1 other identifier: LCCC1938
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity, specificity, and predictive values of CTC cultures' treatment response

  Initiation of trial to 24 months post-initiation

Study Arms (3)

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

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

Bladder Cancer Pts

Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment

Other: Blood Draw

Interventions

Blood Draw OTHER

A blood sample will be collected once, prior to treatment.

Bladder Cancer Pts; GI Cancer Pts; Metastatic Cancer Pts Receiving Molecularly Targeted Therapy

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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Neoplasms; Neoplastic Cells, Circulating; Gastrointestinal Neoplasms; Urinary Bladder Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Z Wang, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 18, 2021

Record last verified: 2021-10