NCT01848015

Brief Summary

To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced gastric cancer after radical resection. To identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

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 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

May 3, 2013

Last Update Submit

May 17, 2015

Conditions

Gastric Cancer

Keywords

CTCs before and after gastrectomy

Outcome Measures

Primary Outcomes (1)

  • CTCs

    2 months

Secondary Outcomes (1)

  • Recurrence of gastric cancer after radical resection

    2 years

Study Arms (1)

CTCs positive

Other: detection of CTCs

Interventions

detection of CTCsOTHER
CTCs positive

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients with advanced gastric cancer accepted radical resection(D2)

You may qualify if:

  • Having signed informed consent
  • Age≥ 18 years old
  • Histologically confirmed gastric adenocarcinoma
  • Preoperative clinical examination and imaging indicating operable disease
  • complete resection (R0 resection)
  • D2 or D2+ resection

You may not qualify if:

  • Other tumor type than adenocarcinoma
  • Patients who have been given preoperative chemotherapy/chemoradiation.
  • Staging investigations or intraoperative exploration indicating inoperable disease
  • R1 or R2 resection
  • D0 or D1 resection
  • Patients unreliable for follow up
  • Past history of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

  • Zhang Q, Shan F, Li Z, Gao J, Li Y, Shen L, Ji J, Lu M. A prospective study on the changes and clinical significance of pre-operative and post-operative circulating tumor cells in resectable gastric cancer. J Transl Med. 2018 Jun 20;16(1):171. doi: 10.1186/s12967-018-1544-1.

    PMID: 29925382DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Lin Shen, MD, PhD

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, MD,PhD

CONTACT

(86)10-88196175lin100@medmail.com.cn

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of GI oncology

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 7, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

CN(1)