Therapeutic Response Evaluation by CTC Expansion System

NCT04972461 | Unknown

• 1 other identifier: N201803020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Circulating Tumor Cells

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced or metastatic solid tumors were enrolled. Eligible patients were ≥ 20 years old and had a life expectancy of more than 3 months.

You may qualify if:

• Patients with malignant tumors

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 18404148 BACKGROUND

• Muller 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.

  PMID: 22894854 BACKGROUND

• Wu YH, Chao HS, Chiang CL, Luo YH, Chiu CH, Yen SH, Liu CY, Chiou JF, Burnouf T, Chen YJ, Wang PY, Chao TY, Hsu SM, Lu LS. Personalized cancer avatars for patients with thymic malignancies: A pilot study with circulating tumor cell-derived organoids. Thorac Cancer. 2023 Sep;14(25):2591-2600. doi: 10.1111/1759-7714.15039. Epub 2023 Jul 20.

  PMID: 37474689 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Expanded circulating tumor cells

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Long-Sheng Lu, MD, Ph.D.

  Taipei Medical University Hospital

  STUDY DIRECTOR

• Jeng-Fong Chiou, MD, Ph.D.

  Taipei Medical University Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: August 8, 2018
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)