Therapeutic Response Evaluation by CTC Expansion System

NCT ID: NCT04972461

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2023-08-07

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.

Detailed 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.

Conditions

Circulating Tumor Cells

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with malignant tumors

Exclusion Criteria

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Long-Sheng Lu, MD, Ph.D.

Role: STUDY_DIRECTOR

Taipei Medical University Hospital

Jeng-Fong Chiou, MD, Ph.D.

Role: STUDY_CHAIR

Taipei Medical University Hospital

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 18404148 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22894854 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37474689 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

N201803020

Identifier Type: -

Identifier Source: org_study_id