NCT03314649

Brief Summary

Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

October 16, 2017

Last Update Submit

May 6, 2019

Conditions

Gastric Cancer

Keywords

Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • prognostic molecular markers

    prognostic molecular markers

    3-year

Secondary Outcomes (2)

  • OS

    3-year

  • DFS

    3-year

Study Arms (1)

Observational study

Patients with gastric cancer and non-cancerous disease planned to have laparotomy

Other: Observational study

Interventions

Observational studyOTHER

Lavage of the Peritoneal Cavity

Observational study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.

You may qualify if:

  • Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
  • PS (ECOG) of 0 or 1 and expected to survive more than 6 months.
  • Written informed consent from the patient.
  • Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.

You may not qualify if:

  • \. Female in pregnancy or lactation. 2. Patients participating in any other clinical trials currently，or participated in other trails within 1 months. 3. Patients with poor compliance or considered to be poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor biopsy, peritoneal lavage

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

December 21, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

CN(1)