Establishment and Application of 3-Dimensional (3-D) Cell Culture Model of Clinical Circulating Tumor Cells (CTCs)

NCT05623748 | Completed

• 1 other identifier: 202101222A3
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion in cancer patient with transitional cell carcinoma and patient without cancer. This project first aims to study the clinical feasibility of utilizing a 3-D cell culture model for the isolation/purification of all possible CTCs in a blood sample in a label-free, viable, and high-purity manner. Through 3-D CTC culture, moreover, the cell number of CTCs can be adequately expanded. All these advantageous features are beyond what is currently possible by using the existing methods. In addition, the harvest of CTCs with above features is found valuable for the subsequent academic researches or clinical studies (e.g. molecular mechanisms underlying cancer metastasis, cancer-related gene mutation, biomarker discovery, and particularly CTCs-based chemotherapy drug testing). These could both facilitate and accelerate scientists to develop new therapeutic solutions for future cancer care.

Conditions

Cell Carcinoma

Keywords

CTCs; 3-D Cell culture; Cell purification; Cell proliferation

Outcome Measures

Primary Outcomes (6)

• the effect of cell culture model for the Cell viability

  optimize the 3-D cell culture model to measure the Cell viability

  baseline

• the effect of cell culture model for the Cell viability

  optimize the 3-D cell culture model to measure the Cell viability

  3 month

• the effect of cell culture model for the Cell viability

  optimize the 3-D cell culture model to measure the Cell viability

  6 month

• the effect of cell culture model for the Cell number

  optimize the 3-D cell culture model to measure the Cell number

  baseline

• the effect of cell culture model for the Cell number

  optimize the 3-D cell culture model to measure the Cell number

  3 month

• the effect of cell culture model for the Cell number

  optimize the 3-D cell culture model to measure the Cell number

  6 month

Secondary Outcomes (9)

• the effect of biochemical factors for glucose concentration

  baseline, pre-intervention

• the effect of biochemical factors for glucose concentration

  3 month

• the effect of biochemical factors for glucose concentration

  6 month

• the effect of biochemical factors for the serum concentration of growth factors/cytokines

  baseline, pre-intervention

• the effect of biochemical factors for the serum concentration of growth factors/cytokines

  3 month

Study Arms (2)

Cancer for CTC culture

participants are cancer patients with transitional cell carcinoma

Procedure: CTCs isolation/purification and cell number expansion

Healthy for CTC culture

enroll participants without cancer

Procedure: CTCs isolation/purification and cell number expansion

Interventions

CTCs isolation/purification and cell number expansion PROCEDURE

In the 1st year research project, investigators will further validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion. In the 2nd and 3rd year research project, investigators will optimize the 3-D cell culture model so as to increase the performances of CTC isolation/purification and proliferation. In the optimization process, investigators will explore the effect of cell culture model (e.g. static or perfusion cell culture, and 3-D cell culture using different 3-D scaffolding materials) or biochemical factors (e.g. glucose concentration, serum concentration, pH, or the supplements of growth factors/cytokines) on the the performances of CTC isolation/purification and proliferation.

Cancer for CTC culture; Healthy for CTC culture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

cancer patients with transitional cell carcinoma

You may qualify if:

• patients who agreed with the content of informed consent of the study protocol
• patients who agreed the researcher to review the medical record
• adults \>20 years old
• Patients have the right to asked withdrawing from the trial at any timepoints
• meet the following requirements (1)cancer participants:cancer patients with transitional cell carcinoma (2)healthy participants:participants without cancer

You may not qualify if:

• Patients who refused the collection of blood and the reviewing of medical record
• The investigators suggest to withdraw

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

New Taipei City, 236, Taiwan

Location

Related Publications (3)

• Oppenheimer SB. Cellular basis of cancer metastasis: A review of fundamentals and new advances. Acta Histochem. 2006;108(5):327-34. doi: 10.1016/j.acthis.2006.03.008. Epub 2006 May 26.

  PMID: 16730054 BACKGROUND

• Mehlen P, Puisieux A. Metastasis: a question of life or death. Nat Rev Cancer. 2006 Jun;6(6):449-58. doi: 10.1038/nrc1886.

  PMID: 16723991 BACKGROUND

• Konstantopoulos K, Thomas SN. Cancer cells in transit: the vascular interactions of tumor cells. Annu Rev Biomed Eng. 2009;11:177-202. doi: 10.1146/annurev-bioeng-061008-124949.

  PMID: 19413512 BACKGROUND

Related Links

• Cancer is a generic term for a large group of diseases that can affect any part of the body. Other terms used are malignant tumours and neoplasms.
• This is the announcements about cancer in the website of Taiwan's DOH

MeSH Terms

Conditions

Hyperplasia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsuan-Chih Kuo

  Ye,Siou-Ru

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: August 31, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)