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Molecular Analysis in Peritoneal Washing Citology for Locally Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098758
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Alexis Luna, Corporacion Parc Tauli

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.


Condition or disease
Gastric Cancer Polymerase Chain Reaction

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Comparative Molecular Analysis CK20, CEA and BER-EP4 in Peritoneal Washing Citology for Locally Advanced Gastric Cancer and Their Ability to Predict Peritoneal Dissemination
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer




Primary Outcome Measures :
  1. specific markers in peritoneal cells [ Time Frame: during surgical intervention ]
    Detection of CK20, CEA and BER-EP4 by PCR technique in peritoneal washing of advanced gastric cancer


Biospecimen Retention:   Samples With DNA
gastric cancer cells in peritoneal washing


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced gastric cancer without macroscopic peritoneal carcinomatosis
Criteria

Inclusion Criteria:

  • Patients with resectable advanced gastric cancer
  • Informed consent

Exclusion Criteria:

  • Macroscopic peritoneal carcinomatosis
  • Non operable patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098758


Contacts
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Contact: Alexis Luna, MD PhD 0034937231010 ext 21458 Aluna@tauli.cat

Locations
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Spain
Parc Tauli Hospital Universitari Recruiting
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Alexis Luna, MD PhD Corporación Parc Taulí
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Responsible Party: Alexis Luna, MD PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03098758    
Other Study ID Numbers: CIRPT_AL2017_1
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexis Luna, Corporacion Parc Tauli:
Polymerase Chain Reaction
gastric cancer
citology
peritoneal washing
CK20
CEA
BER-EP4
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases