Trial document
DRKS00012512
Trial Description
Title
Pulmonal lymph node micrometastasis in N0 patients with colorectal carcinoma after pulmonary metastasectomy
Trial Acronym
[---]*
URL of the Trial
[---]*
Brief Summary in Lay Language
This is a retrospective, open, monocentric, in vitro study.
The aim of the study is to detect micrometastases in pulmonary and mediastinal lymph nodes by
means of molecular detection after metastasectomy, which have been diagnosed without tumor in
the simple sectional diagnosis.
Brief Summary in Scientific Language
Colorectal carcinoma is a malignant tumor of the intestine or rectum. It is the second most common malignancy of the woman and the third most common malignancy of the male, whereby it is the second most common cause of death in Germany.
Tumor growth has already taken place in up to 25% of the cases of diagnoses, while liver and lung are the most frequently affected organs. The lymph nodes in the lung are not radically removed during metastasectomy. The examination of the lymph nodes taken is performed by H.E. Coloring. Studies using immunohistochemical and / or genetic methods, the lymph nodes taken during primary tumor surgery, have shown that micrometastases occur in lymph nodes and have a negative effect on the survival rate and relapse rate. There is currently no investigation of pulmonary / mediastinal lymph nodes in metastatic colorectal carcinoma. A higher recurrence rate and / or poorer survival rate was described in studies which produced positive lymph node detection in pulmonary metastasesctomy by means of only intersection diagnosis and H.E. staining. Therefore, the aim is to detect micrometastases in pulmonary and mediastinal lymph nodes by means of molecular detection after metastasectomy, which have been diagnosed without tumor in the simple sectional diagnosis. This study, which can show a link between micrometastases in lymph nodes after pulmonary metastasisctomy and reduced survival rate and / or increased recurrence rate, can lead to better therapy, in the sense of extended oncological aftertreatment, modification of the surgical technique or also avoidance of over-therapy.
Organizational Data
- DRKS00012512
- 2017/10/09
- [---]*
- yes
- Approved
- 316/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- [---]*
Health Condition or Problem studied
- C34 - Malignant neoplasm of bronchus and lung
Interventions/Observational Groups
-
• Retrospective opacity of patients undergoing surgical resection of pulmonary metastases with lymph node removal in colorectal carcinomas.
• Creation of a database with clinical and pathological parameters.
• Contact the Institute of Pathology Freiburg for the testing of tissue samples
• Establish detection of micrometastases via CK 20 by RT-PCR / RT-qPCR
• Statistical evaluation of the collected data.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Treatment
- Single (group)
- N/A
- N/A
Primary Outcome
detection of micrometastases
Secondary Outcome
overall survival, recurrence rates and disease-free interval
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2017/09/22
- 100
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
-Patients with colorectal cancer and curative resection of pulmonary metastases with lymph node resection at controlled primary tumor
- >18 years old
- patients of Thoracic Surgery during 2008 and 2017
Exclusion Criteria
Metastasis resection without lymph node removal
Addresses
-
start of 1:1-Block address primary-sponsor
- UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie Klinik für Thoraxchirurgie
- Hugstetter Str. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Department Chirurgie Universitätsklinikum Freiburg
- Mr. Dr. med Laurin Titze
- Hugstetter Strasse 55
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 (0)761 270 24590
- [---]*
- laurin.titze at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Department Chirurgie Universitätsklinikum Freiburg
- Mr. Dr. med Laurin Titze
- Hugstetter Strasse 55
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 (0)761 270 24590
- [---]*
- laurin.titze at uniklinik-freiburg.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie Klinik für Thoraxchirurgie
- Hugstetter Str. 55
- 79106 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*