S1119 Peruvian H. Pylori Water Contamination Study | NCT01512875

Studies
S1119 Peruvian H. Pylori Water Contamination Study

NCT01512875

Sponsor

SWOG Cancer Research Network

Status

Completed

Last Update Posted

Nov 17, 2015Estimated

Enrollment

107Actual

Phase

Not provided

Conditions

Helicobacter Pylori Infection

Interventions

Not provided

Countries

Peru

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Aug 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jan 13, 2012

First Submission Date that Met QC Criteria

Jan 18, 2012

First Posted Date

Jan 19, 2012Estimated

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

Nov 16, 2015

Last Update Posted Date

Nov 17, 2015Estimated

Name	Class
University of Michigan	OTHER
Hope Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to elucidate the role of drinking water derived from the public source in Lima, Peru and transmission of H. pylori infection using genotypic techniques.

Detailed Description

The objective of this study is to detect the presence of Helicobacter Pylori in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima (Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Martin de Porres, Villa El Salvador, and Villa Maria del Triunfo) with high and low incidence of gastric carcinoma. The secondary objective of this study is to establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.

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

Retention

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
biopsy proven H. pylori		Patient must have lived in the districts of Lima, Peru listed in the protocol.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detect H. pylori in public drinking water of Lima Peru	To detect the presence of Helicobacter Pylori (H. pylori) in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima, Peru (districts detailed in protocol).	within 1 year of receving last sample

Secondary Outcomes

Measure	Description	Time Frame
Correlation of H. pylori in water and those of stomachs of patients with symptoms	To establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.	Within 1 year of receiving last sample

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults between the ages of 21-70 years old who have lived for more than 10 years in the Lima districts listed in protocol,
who have a biopsy proven diagnosis of infection by H. pylori.
participants must be in good general condition, mentally competent and able to provide informed consent;
must not show evidence of dehydration or jaundice;
must be willing to complete the patient questionnaires.
participants must not have known allergies to any of the antibiotics used in the study.

Exclusion Criteria:

pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Residents of the following districts of Lima, Peru: Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Luis, San Martin de Porres, Via El Salvador, Villa Maria del Triunfo.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Valdivieso, M.D.	SWOG Cancer Research Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Peruana Cayetano Heredia		Lima			Peru