Screening for Familial Gastric Cancer in First Degree Relatives

NCT01727908 | Terminated DMC

• 1 other identifier: Protocol ID 2012/270
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in first degree relatives of individuals with familial gastric cancer.

Conditions

Malignant Neoplasm of Stomach; Carcinoma, Diffuse Type; Intestinal Type Adenocarcinoma of Stomach; Relative (Related Person)

Keywords

Familial Gastric Cancer Screening

Outcome Measures

Primary Outcomes (1)

• The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.

  all patients will have a follow up of five years, during which four endoscopies will be performed

Secondary Outcomes (3)

• To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.

  all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed

• To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).

  after three years of follow up these data will be assessed

• To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.

  during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.

Study Arms (2)

Endoscopy without staining of the mucosa

NO INTERVENTION

Endoscopy with staining of the mucosa.

EXPERIMENTAL

Other: Endoscopy with staining of the mucosa

Interventions

Endoscopy with staining of the mucosa OTHER

Staining of the gastric mucosa with acetic acid and Indigocarmine

Endoscopy with staining of the mucosa.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult (≥ 18 yrs), female and male relatives
• fully legal competent (to simplify the common consent agreement for blood withdrawal, DNA analysis and serial endoscopies.)
• individuals that signed the common consent agreement
• first degree relative of an individual with diffuse gastric cancer from a FDGC-family, without proven mutation,
• OR: 2 or more individuals with gastric carcinoma, at least one \< 50 yrs
• OR: 3 or more individuals with (diffuse/intestinal/other type) gastric carcinoma, any age
• OR 1 individual with any type gastric carcinoma \< 40 yrs

You may not qualify if:

• immature individuals
• actual gastric ulcer or gastric bleeding
• previous diagnosis of gastric cancer
• hypersensitivity to Indigocarmine
• individuals with co-morbidity which might increase the sedation and/or endoscopy risk: COPD Gold III/IV Cardiac failure Increased bleeding tendency or use of medication which increases bleeding tendency

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre

Nijmegen, PO BOX 9101, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tanya M Bisseling, M.D.Ph.D.

  Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre

  PRINCIPAL INVESTIGATOR

• Fokko M Nagengast, M.D.Ph.D.

  Department of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 16, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 16, 2019

Record last verified: 2017-04

Locations

NL (1)