Circulating Tumor Cells (CTCs) in Advanced Gastric Cancer | NCT01848015

Studies
Circulating Tumor Cells (CTCs) in Advanced Gastric Cancer

NCT01848015

Sponsor

Peking University

Status

Unknown status

Last Update Posted

May 19, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Gastric Cancer

Interventions

detection of CTCs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

May 3, 2013

First Submission Date that Met QC Criteria

May 6, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2015

Last Update Posted Date

May 19, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
CTCs positive			Other: detection of CTCs

Name	Type	Description	Arm Group Labels	Other Names
detection of CTCs	Other		CTCs positive

Measure	Description	Time Frame
CTCs		2 months

Measure	Description	Time Frame
Recurrence of gastric cancer after radical resection		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Shen, MD,PhD	Contact	(86)10-88196175		lin100@medmail.com.cn

Overall Officials

Name	Affiliation	Role
Lin Shen, MD, PhD	Peking University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking cancer hospital	Recruiting	Beijing	Beijing Municipality	100142	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29925382	Derived	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.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms