NCT05399719

Brief Summary

Clinical and preclinical evidence reveal that cancer cells may fuse with hematopoietic cells to obtain properties including migration, proliferation and drug resistance. The investigators hypothesize that cancer cell-macrophage fusion hybrids may lead to pancreatic cancer desmoplasia and progression. Murine tumor models using cre-loxP or gender-mismatched xenografts as well as pdx-cre-KrasLSL-G12D mice after bone marrow transplantation from reporter ROSA mice were established. Fusion hybrids and macrophage markers were detected using immunofluorescence staining and flowcytometry. In vitro co-culture using cre-loxP or dual fluorescence methods of pancreatic cancer cells with macrophages was used to evaluate the frequency of fusion phenomenon. The proliferative, migratory and resistant phenotypes of purified fusion hybrids were measured. Differentially expressed genes between fusion hybrids and non-fused cancer cells were compared by Affymetrix microarray analysis. The investigators are going to collect tumor tissues from cancer patients who received allographic bone marrow transplantation before. We will evaluate Y chromosome or short tandem repeats to identify donor- derived genes in cancer cells and demonstrate the clinical evidence of fusion between cancer cells and macrophages. The tumor tissues will be collected from the Pathology Department. Ten slides of 4-8um will be collected from twenty patients enrolled according to the inclusion criteria. The investigator will collect peripheral mononuclear cells from healthy volunteer ( eg. Donors for bone marrow transplantation) or hyperemia patients. The mononuclear cells will be induced to differentiate into macrophages and will be co-cultured with cancer cells in order to purify fusion hybrids. The fusion hybrids between cancer cells and macrophages will be evaluated for biologic characters including proliferation, radio-sensitivity, migration etc. The investigators planned to collect blood samples from Department of Laboratory Medicine, Blood bank. Thirty subjects of healthy volunteer or hyperemia patients will be enrolled. Ten to 20ml peripheral blood will be collected from each subjects for one time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

April 16, 2024

Status Verified

June 1, 2023

Enrollment Period

2.8 years

First QC Date

May 25, 2022

Last Update Submit

April 14, 2024

Conditions

Keywords

fusion hybrids, macrophages, cancer cells

Outcome Measures

Primary Outcomes (1)

  • donor derived genes in recipients' tumor tissue

    Y chromosome and short tandem repeat study of recipients' tumor tissue and donor blood

    0-30 years

Study Arms (2)

Tumor tissue from BMT recipients

tumor tissue sections from patients received allogeneic bone marrow transplantation before

Peripheral blood from healthy volunteer

peripheral blood from peripheral blood stem cell donors or healthy control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prospectively collect peripheral mononuclear cells: 30 healthy volunteer including peripheral blood stem cell donors, hyperemia. Retrospectively collect tumor tissue: 20 patients. malignant cancer patients with history of receiving bone marrow transplantation.

You may qualify if:

  • prospective
  • normal peripheral blood laboratory results within one week.
  • hematopoietic cell growth factors are allowed for peripheral blood stem cell donors.
  • hyperemia patients. .
  • age 20 to 70.
  • retrospective
  • recipient of bone marrow transplantation and developed malignant tumor after transplantation.
  • tumor was resected or biopsied and preserved in Pathology Department. 4-8um thick, 10 slices.

You may not qualify if:

  • prospective
  • malignant cancer patients with no recurrent disease for less than 5 years
  • major cardiovascular disease, immnologic disease, pregnancy.
  • long term users of immuno-suppressants and steroids.
  • retrospective
  • (1)none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cancer Research, National Health Research Institutes

Miaoli, 35053, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

paraffin section of tumor tissues, peripheral blood

Study Officials

  • Ming Yao, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Ju Ch'ang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 1, 2022

Study Start

May 25, 2022

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

April 16, 2024

Record last verified: 2023-06

Locations