Therapeutic Response Evaluation by CTC Expansion System

Circulating Tumor Cells Clinical Trial

Official title:

Evaluate the Therapeutic Response by Using in Vitro Circulating Tumor Cell Expansion System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04972461
• Other study ID #: N201803020
• Status: Enrolling by invitation
• Start date: August 8, 2018
• Est. completion date: August 7, 2023

Study information

• Verified date: October 2022
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Among biomarkers, CTCs are a convenient, sensitive and biologically informative option. CTC detection could be considered a real-time "liquid biopsy" approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low, so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this study, we develop a short-term CTC expansion protocol combined with a new surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform, which provides an opportunity to monitor response to therapy noninvasively.

Description:

CTC detection could be considered a real-time "liquid biopsy" approach and contains several advantages such as minimally invasive, easy and safe to perform, and multiple samples can be taken over time, better prognosis to indicate an elevated risk of metastases, improved therapy monitoring, providing live disease status information., However, the number of CTCs is very low so the establishment of cell culture from CTCs becomes the most challenging over the past year. In this proposal we will develop a short-term CTC expansion protocol through combine with a new type of surface coating technique. Expanded circulating tumor cells will provide genetic information and develop oncology drug screening platform which provide an opportunity to noninvasively monitor response to therapy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Patients with malignant tumors

Exclusion Criteria:

• Unsuitable for recruitment by clinical judgement or non-compliance with regular follow-up.

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Müller V, Riethdorf S, Rack B, Janni W, Fasching PA, Solomayer E, Aktas B, Kasimir-Bauer S, Pantel K, Fehm T; DETECT study group. Prognostic impact of circulating tumor cells assessed with the CellSearch System™ and AdnaTest Breast™ in metastatic breast cancer patients: the DETECT study. Breast Cancer Res. 2012 Aug 15;14(4):R118. doi: 10.1186/bcr3243. — View Citation

Pantel K, Brakenhoff RH, Brandt B. Detection, clinical relevance and specific biological properties of disseminating tumour cells. Nat Rev Cancer. 2008 May;8(5):329-40. doi: 10.1038/nrc2375. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate drug sensitivity profiles of the expanded circulating tumor cells with the clinical treatment response.	CTC was expanded in vitro culture system and drug sensitivity profile to disease-specific panels was obtained. Clinical treatment response and drug sensitivity profile were analysed with 2 by 2 contingency tables. The evaluation of clinical response rate used by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Briefly, C+ refers to patients with clinical disease control (complete response, partial response, and stable disease), and C- refers to patients were found with worsening diseases (PD). Patients that did not fit into either category were listed as non-evaluable. The drug sensitivity profiles were categorized into E+ and E-. In class E+, at least one chemical in the evaluable treatment regimen was found to kill more than 30% of the cells in the CTC culture system. In class E-, all chemicals in the evaluable treatment regimen were found to kill less than 30% of the cells in the CTC culture system.	CTC was expanded in vitro and drug sensitivity profile to disease-specific panels was obtained. The patient continued with the planned treatment by the treating physician and follow up information was obtained 3 months after blood sampling.