The clinical significance of genetics factors research to refine the diagnosis, estimate prognosis and risk of recurrence after succesful pancreatic cancer resection.

Phase 1

• Conditions: The aim of the study to estimate frequence of epigenetics changes in pancreatic cancer and to assess the signidicance of apllication of the intravenous contrast agent during endosonography to better visualusation of the lesions.; MedDRA version: 14.0 Level: LLT Classification code 10016335 Term: Feeling hot and cold System Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.0 Level: LLT Classification code 10037872 Term: Rash NOS System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.0 Level: LLT Classification code 10032168 Term: Other insomnia System Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.0 Level: LLT Classification code 10008481 Term: Chest pain - cardiac System Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.0 Level: LLT Classification code 10064907 Term: Functional abdominal pain System Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.0 Level: LLT Classification code 10048324 Term: Dizziness aggravated System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0 Level: LLT Classification code 10033777 Term: Paraesthesia distal System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.0; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2011-003248-36-CZ
• Lead Sponsor: Central Military Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

patients with chronic pancreatitis
patients with pancreatic focal mass

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

age under 18 years
pregnancy and lactation
disagreement with participation in the study
chronic pancreatitis without mass
patients with severe heart and pulmonary failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified