Trial document




drksid header

  DRKS00007565

Trial Description

start of 1:1-Block title

Title

Prospective, interventional study on the characterization of circulatory
Tumor cells and nucleic acids in patients undergoing a
Lung carcinoma surgery or pulmonary metastasisctomy
(Pilot study)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

It is an interventional, prospective, monocentric study. The aim of the study is the detection and characterization of circulating tumor cells and nucleic acids as well as comparative analysis of the surgical preparation in patients undergoing pulmonary carcinoma surgery or pulmonary metastasisctomy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In a prospective pilot study, patients undergoing pulmonary surgery due to a lung carcinoma or pulmonary metastases are included in the isolation of circulating tumor cells (CTC) and nucleic acids (DNA / RNA).
The blood samples are taken intra- and postoperatively.
The removal of intraoperative blood samples allows the determination of the cells and nucleic acids released in the region of the immediate tumor discharge, and thus the possibility of the targeted analysis of the elements directly from the tumor compartment and the comparison with systemic markers. This provides new insights as well as more specific results on the correlation of the specific markers with histopathological and prognostic factors, and thus provides evidence of their importance in the pathogenesis of tumors and metastases.

Due to a protocol amendment in May 2017 the following changes were made to the protocol:

-Prolongation of the term to 31.08.2018
-Expanding the investigation of additional markers
-Project leader and deputy change

The amendment was approved by the ethics committee Albert-Ludwigs-University Freiburg on August 11 2017.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007565
  •   2015/04/10
  •   [---]*
  •   yes
  •   Approved
  •   4/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Group A - Tumor Patients:
    Intraoperatively, the patient is treated according to incision and prior removal of the primary or secondary tumors, approximately 20 ml of blood were taken off via a routinely available peripheral access. In addition, 20 ml of blood are also taken from the patient through the puncture of a pulmonary vein, which represents the immediate outflow of the pulmonary lobe with the largest tumor load, using a 20-gauge cannula.
    There is a further postoperative blood sampling between days 5 and 10 in the course of the routine blood collection.

    In addition to blood samples, tissue samples are also required. These are obtained intra-operatively and have a size of approximately 0.5 × 0.5 × 0.5 cm 3. Additional extraction of a healthy lung tissue sample (0.5 x 0.5 x 0.5 cm3) at the edge of the removed surgical preparation is obtained. The preparations are removed by the appropriate surgeon without the evaluation of the surgical preparation by the pathology. Patients are telephone at 6-month intervals for a total of 2 years postoperatively Contact or present clinical data.
  •   Group B - Patients with lung surgery for other reasons:
    Intraoperatively, the patient is taken once after cutting over the routinely available arterial access or via the central venous access 20 ml of blood. In addition, blood is taken to the patient via a puncture of a pulmonary vein with a 20-gauge cannula. We then contacted the patient at 6-monthly intervals for a total of 2 years postoperatively. Blood samples are kept for possible future questions in the research laboratories of the Department of Thoracic Surgery, University of Freiburg.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Creation of a molecular profile of the present tumor disease using the
Analysis of CTCs and circulating nucleic acids in the local tumor compartment and systemically in primary and secondary lung tumors

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Tumor recidiv
- Overall survival
- Genetic consistency of the CTCs in the local tumor compartment and systemic
- Comparison of different methods and removal points for the isolation of CTCs
-comparison cDNA, miRNA and clncRNA in the surgical preparation with the circulating RNAs systemically as well as from the immediate tumor discharge
- Expression of driver mutations of the CTCs

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/05/07
  •   110
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Group A:
- submission of written consent from the patient after informing
- Age ≥ 18 years
Diagnosis of primary lung carcinoma or pulmonary metastases
- indication for surgical resection (atyp. Resection, lobectomy,
Pneumonectomy, metastasisctomy)
- In patients who are operated on a malignancy, the
Histopathological findings including the adequate examinations
be. No additional biopsy, examination or intervention must be within the framework
Of the study.


Group B:
-template the written consent of the patient after informing
- Age ≥ 18 years
- Patients who have neither a history nor a suspected malignancy
(Other than basal cell carcinoma) and a lung operation due to a benign
Cause a basic disease.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Group A:

pregnancy
- Diagnosis of a second (synchronous) malignoma, except basal cell carcinoma.
- hemoglobin <8 g / dl on the morning of operation
- Intraoperative transfusion of more than four erythrocyte concentrates

Group B:

pregnancy
- Diagnosis of malignancy other than basal cell carcinoma.
- hemoglobin <8 g / dl on the morning of operation
- Intraoperative transfusion of more than four erythrocyte concentrates. No more
Blood collection will be taken during or on the first postoperative day.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start 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
    • UNIVERSITÄTSKLINIKUM FREIBURGDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • UNIVERSITÄTSKLINIKUM FREIBURGDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.