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

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

NCT ID: NCT05623748

Condition: Cell Carcinoma

Conditions: Official terms:
Neoplastic Cells, Circulating

Conditions: Keywords:
CTCs
3-D Cell culture
Cell purification
Cell proliferation

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Procedure
Intervention name: CTCs isolation/purification and cell number expansion
Description: 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.
Arm group label: Cancer for CTC culture
Arm group label: Healthy for CTC culture

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.

Detailed description: Circulating tumor cells (CTCs), the rare cell species present in the blood, are considered to mainly contribute to cancer metastasis or relapse. Thus, the detection of CTCs is regarded as an essential clinical tool to detect metastatic cancer. Moreover, CTCs can be the therapeutic target of metastatic cancer care. Therefore, the use of viable CTCs as a biopsy to select therapeutic regimens (e.g. CTCs-based anti-cancer drug testing) opens up a promising route to realize personalized cancer therapy. With the recent advances in cell isolation or detection techniques, various novel approaches have been actively proposed to isolate/detect CTCs. Nevertheless, most of current methods might not be able to obtain the all possible, viable, and label-free CTCs with adequate cell purity and cell number for the subsequent CTCs-based anti-cancer drug testing or other bioassays. To tackle the above technical hurdles, the research project proposes the use of a specific 3-D cell culture technique for the isolation/purification, and cell number expansion of CTCs. The working principle is based on our preliminary findings showing that the human leukocytes will die away in 3-D cell culture condition, whereas the CTCs will tend to aggregate and proliferate in such environment. Based on this phenomenon, the 3-D CTC cell culture can be used to isolate and purify the viable CTCs from the leukocyte background in a negative selection, and label-free manner, enabling the harvest of the all possible CTCs in a blood sample. Furthermore, the proliferation of CTCs in such 3-D cell culture can adequately expand the cell number of CTCs for the subsequent applications, which is currently impossible using the existing methods. 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 solation/purification and proliferation. As a whole, investigators hope the proposed research project can find out an efficient and effective approach to isolate/purify/expand clinical CTCs in a viable, label-free, and high-purity manner. These harvested CTCs are valuable for the subsequent analytical tasks.

Criteria for eligibility:

Study pop:
cancer patients with transitional cell carcinoma

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: 1. patients who agreed with the content of informed consent of the study protocol 2. patients who agreed the researcher to review the medical record 3. adults >20 years old 4. Patients have the right to asked withdrawing from the trial at any timepoints 5. meet the following requirements (1)cancer participants:cancer patients with transitional cell carcinoma (2)healthy participants:participants without cancer Exclusion Criteria: 1. Patients who refused the collection of blood and the reviewing of medical record 2. The investigators suggest to withdraw

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Chang Gung Memorial Hospital

Address:
City: New Taipei City
Zip: 236
Country: Taiwan

Status: Recruiting

Contact:
Last name: Hsuan-Chih Kuo

Phone: 0975366137
Email: wisdom2000@gmail.com

Contact backup:
Last name: Chia-Hsun Hsieh

Phone: 0975360665
Email: hsuanchihkuo@gmail.com

Start date: August 31, 2021

Completion date: May 31, 2024

Lead sponsor:
Agency: Chang Gung Memorial Hospital
Agency class: Other

Source: Chang Gung Memorial Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05623748
http://www.who.int/mediacentre/factsheets/fs297/en/
http://www.hpa.gov.tw/BHPNet/Web/Index/Index.aspx