NCT03156777

Brief Summary

Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.

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 Jan 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 17, 2017

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

November 30, 2016

Last Update Submit

May 15, 2017

Conditions

Circulating Tumor CellsGastric Cancer

Keywords

Gastric cancer; Circulating tumor cells; Prognosis

Outcome Measures

Primary Outcomes (1)

  • Number of circulating tumor cell (CTC)

    Number of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy

    Up to 2 years from start of study

Secondary Outcomes (3)

  • Profile and Portion of circulating tumor cell (CTC)

    Up to 2 years from start of study

  • Progression-free survival

    Up to 3 years from start of the study

  • Overall survival

    Up to 5 years from start of the study

Eligibility Criteria

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

Advanced gastric cancer patients

You may qualify if:

  • Subjects eligible for enrollment must meet all of the following criteria:
  • Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
  • Men or women aged \>= 18 years and \<=75 years.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2.
  • Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction.
  • Metastatic disease or locally advanced disease not amenable to curative surgery.
  • Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
  • Life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment.
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
  • No prior chemotherapy for advanced disease. -

You may not qualify if:

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Gastric carcinoid, sarcomas, or squamous cell cancer.
  • Pregnant or lactating females.
  • Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
  • Active Hepatitis B or C or history of an HIV infection.
  • Active uncontrolled infection. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, CirculatingStomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wei Lu, M.D. & Ph.D.

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Yinbing Liu, M.D. & Ph.D.

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Xin Zhou, M.D. & Ph.D.

CONTACT

+862125078999xinhuacru@163.com

Beiqing Jiang

CONTACT

+862125078922xinhuakeyan@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

May 17, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

May 17, 2017

Record last verified: 2016-11

Locations

CN(1)