Using a 3D Culture Model for Circulating Tumor Cells Combined With Molecular Bioassays in Patients With HNSCC Cancer

NCT06755762 | Recruiting

• 1 other identifier: 202301979B0
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer has been a significant cause of human death in the recent two decades, although detection, diagnosis, and cancer treatments improved and evolved rapidly. Till now, the reasons why some cancer recurs and others do not remain unclear. Since 2004, circulating tumor cell (CTC) has been well-recognized that CTCs in the circulatory system are associated with cancer metastasis. The fundamental studies of CTCs hold tremendous potentials for probing the biological insights on the molecular mechanisms underlying cancer metastasis, cancer-related gene mutation, or biomarker discovery. However, the low purity (one of the natural limitations) of isolated samples often hampered CTC-directed studies' utility. For that, investigators used a well-established device (ODEP, optically-induced-dielectrophoresis) to isolate viable and high-purity CTCs for the following investigations. Investigators team developed a protocol in the past months and succeeded in cultivating CTCs (near 100%) for further drug tests and had a technology platform of organoid culture system developing in 2020. The preliminary results of the experiments showed a promising combination. That urges investigators to propose a 3-year project investigating CTC culture in the organoid system to look at (1) the behavior of CTCs in organ cell background (organoid), (2) the influences of different background cells, (3) the different in-vitro (or in-organoid) response of CTCs to specific drugs (pembrolizumab, nivolumab, cetuximab, cisplatin, 5-FU, taxanes) of head and neck squamous cell carcinoma. In the meantime, investigators will look at the genomic alterations of those CTCs growing fast and well in the organoid systems to find possible precipitating metastasis genes at a scale of cell (CTC) level. Investigators believe that the project is doable and possibly help human cancer control and understanding.

Conditions

Circulating Tumor Cell; HNSCC

Keywords

circulating tumor cell; organoid; HNSCC

Outcome Measures

Primary Outcomes (4)

• cell density and numbers

  CTC number low(\<10) and high(\>100)

  baseline

• cytokines detection-EpCAM

  For negative selection of CTCs by the negative selection system.To deplete EpCAM leukocytes, a EpCAM depletion cocktail was mixed with the collected nucleated cells

  baseline

• cytokines detection-CD-45+ leukocytes

  For negative selection of CTCs by the negative selection system.To deplete CD-45+ leukocytes, a CD-45 depletion cocktail was mixed with the collected nucleated cells

  baseline

• counting of EpiCAM-positive and Hoechst-positive cells

  Positive Selection method.The cell recovery is determined by counting EpiCAM-positive and Hoechst-positive cells under microscope with hemocytometer. Human samples will go through the whole processes without spiking steps

  baseline

Study Arms (2)

control

healthy donors

Other: Organoid 3D culture

experimental

HNSCC patients

Other: Organoid 3D culture

Interventions

Organoid 3D culture OTHER

Investigate different normal cells (lung, bone, soft tissue, liver, etc) as metastatic organs to simulate the behaviors of CTCs in metastatic sites

Also known as: without cancer patients

control; experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Develop the CTC culture system (isolated by negative selection strategy and ODEP platform) and organoid 3D culture system for CTC from health participants and HNSCC cancer participants.

You may qualify if:

• age ≥ 18
• agree with blood drawing and follow the procedure of the trial
• a.health participants:without cancer over 5 yaers b.cancer participants:pathology: metastatic HNSCC patients

You may not qualify if:

• health participants:with serious illness
• cancer participants:none

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA was isolated from blood to control for germline variants using the DNeasy Blood and Tissue Kit.Biallelic drop out was calculated from germline heterozygous single-nucleotide polymorphisms (SNPs)

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Chia-Hsun Hsieh, PhD

  Division of Oncology, Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Chia-Hsun Hsieh, PhD

CONTACT

0975366137; wisdom5000@gmail.com

Hsuan-Chih Kuo, PhD

CONTACT

0975360665; hsuanchihkuo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Attending Physicians

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 1, 2025
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

TW (1)