NCT03098758

Brief Summary

Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a recognized prognostic utility. However sensibility of this study is not appropriate. Studies with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging information. Objective: To analyze the sensibility and specificity of the expression of CK20, CEA and Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without clinical evidence of peritoneal carcinomatosis. Methodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of peritoneal recurrence.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

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

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

2.9 years

First QC Date

March 28, 2017

Last Update Submit

July 23, 2019

Conditions

Gastric CancerPolymerase Chain Reaction

Keywords

Polymerase Chain Reactiongastric cancercitologyperitoneal washingCK20CEABER-EP4

Outcome Measures

Primary Outcomes (1)

  • specific markers in peritoneal cells

    Detection of CK20, CEA and BER-EP4 by PCR technique in peritoneal washing of advanced gastric cancer

    during surgical intervention

Eligibility Criteria

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

Patients with advanced gastric cancer without macroscopic peritoneal carcinomatosis

You may qualify if:

  • Patients with resectable advanced gastric cancer
  • Informed consent

You may not qualify if:

  • Macroscopic peritoneal carcinomatosis
  • Non operable patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Tauli Hospital Universitari

Sabadell, Barcelona, 08208, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

gastric cancer cells in peritoneal washing

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Alexis Luna, MD PhD

    Corporación Parc Taulí

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Luna, MD PhD

CONTACT

0034937231010Aluna@tauli.cat

Study Design

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

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

May 8, 2017

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

ES(1)