Clinical trial NCT04972461: Therapeutic Response Evaluation by CTC Expansion System
Official title: Evaluate the Therapeutic Response by Using in Vitro Circulating Tumor Cell Expansion System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Tumor Cells
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 500
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with malignant tumors

Exclusion Criteria:

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

Primary outcomes:
measure: To correlate drug sensitivity profiles of the expanded circulating tumor cells with the clinical treatment response.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Long-Sheng Lu, MD, Ph.D.
role: STUDY_DIRECTOR
affiliation: Taipei Medical University Hospital
name: Jeng-Fong Chiou, MD, Ph.D.
role: STUDY_CHAIR
References:
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.
citation: 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.