NCT03581435

Brief Summary

This research will be the first study for exosome purified from blood in gallbladder carcinoma patients. Proteomics studies will be done in both tumor tissue and the circulating exosome from blood specimens. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.

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 Jan 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

June 26, 2018

Last Update Submit

July 8, 2018

Conditions

ProteinosisGallbladder Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Characterization of the protein profile in tumor derived exosomes from the gallbladder carcinoma patients

    Proteomics studies will be done in both tumor tissue and the circulating exosomes from blood specimens. The specific protein A in the circulating exosomes from the gallbladder carcinoma patients will be selected for further analysis.

    Up to 2 years from start of study

  • The expression of protein A in the circulating exosomes from patients

    The expression of protein A （which is selected from outcome 1） in the circulating exosomes from patients will be detected by flow cytometry analysis. The ROC curve of A+ circulating exosomes will be done to compare with the clinical standard tumour biomarker (e.g. CA199) for patients with gallbladder carcinoma patients.

    Up to 2 years from start of study

Study Arms (2)

gallbladder carcinoma patients

Cases will be the patients with newly-diagnosed gallbladder carcinoma.

The controls

The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators will conduct a case-control study in 11 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. A total of 50 patients with gallbladder carcinoma will be recruited.

You may qualify if:

  • Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)

You may not qualify if:

  • The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum Tumor tissue

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice-president，Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 10, 2018

Study Start

January 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 1, 2019

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

CN(1)