Gastric Cancer Clinical Trial
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
| NCT number | NCT03098758 |
| Other study ID # | CIRPT_AL2017_1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 8, 2017 |
| Est. completion date | April 2020 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | April 2020 |
| Est. primary completion date | April 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with resectable advanced gastric cancer - Informed consent Exclusion Criteria: - Macroscopic peritoneal carcinomatosis - Non operable patients |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Parc Tauli Hospital Universitari | Sabadell | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Corporacion Parc Tauli |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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