NCT03778710

Brief Summary

D2 gastrectomy is standard treatment of early gastric cancer in Japan but in other countries there is still some discord, especially in Europe and North America. Although the quantity of metastasis cancer in lymph node defines survival regardless of which country the patient is treated, the total number of lymph nodes harvested is an important factor to predict accurate staging and/or D2 gastrectomy. Both of the number total lymph nodes and the metastasis lymph node status in gastric cancer are important factors to decide each prognosis. This study evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph node ratio (LNR) status to determine the recurrence rate after curative resection of gastric

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

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

December 16, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

December 16, 2018

Last Update Submit

March 24, 2019

Conditions

Keywords

Lymph node metastasis, Gastric cancer

Outcome Measures

Primary Outcomes (2)

  • The correlation of lymph node ratio and survival of gastric cancer patients

    correlation of lymph node ratio and survival of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.

    5 year

  • The correlation of lymph node ratio and prognosis of recurrence of gastric cancer patients

    correlation of lymph node ratio and recurrence of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.

    5 year

Secondary Outcomes (1)

  • The correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients

    5 year

Eligibility Criteria

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

All patients who presented with gastric cancer after curative surgery resection from January 1, 1995 to December 31, 2016 in Ramathibodi Hospital.

You may qualify if:

  • Gastric cancer after curative surgery resection
  • No received neoadjuvant therapy
  • Patients have tissues confirmed by Pathology
  • Staging used esophagogastroduodenoscopy (EGD) or imaging, including ultrasonography, Computer Tomography (CT) or Magnetic Resonance Imaging (MRI
  • Surgery was performed for curative intent and D2 lymphadenectomy and according from Japanese guideline for gastric cancer

You may not qualify if:

  • Distant metastasis during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Stomach NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chairat Supsamutchai, MD

    Ramathibodi Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 19, 2018

Study Start

December 18, 2018

Primary Completion

January 30, 2019

Study Completion

February 20, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations