Trial document





This trial has been registered retrospectively.
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  DRKS00015005

Trial Description

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Title

Clinical registry for patients with primary an recurrent rectal cancer

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Trial Acronym

Rectal cancer registry

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Registry for patients with rectal cancer or recurrent rectal cancer. Data related to the treatment of rectal cancer (chemotherapy, radiotherapy and surgery) will be collected in a electronic database. Follow-up data regarding the response to specific treatment or disease recurrence will be documented. Furthermore, adverse events related to the disease and treatment will be analyzed.
The data collection will provide useful insights into the quality of treatment of rectal caner patients at the University Medical Center Freiburg. We might be able to identify patient and tumor characteristic which help to better select individual therapies and might improve the quality of our treatment. The results can be compared with national and international registries.
The collection and analysis of patient related data follow the latest statute for privacy protection.

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Brief Summary in Scientific Language

The study will build a clinical database on patients with primary rectal cancer and recurrent rectal cancer.

Clinical databases and registries include the systematic collection of medical data of a specific population of patients defined by a particular disease, therapy or other property. This data collection meets criteria of an observational clinical study.

Potential goals of clinical databases and clinical registries include epidemiological reporting, evaluation of quality of care and assessment of the safety and efficacy of therapeutic measures. They are also an important tool to support clinical research.

With regard to quality assurance, features are collected that can directly or indirectly map the quality of care. On the one hand, comparisons with other, external institutions, but also the temporal development within an institution can be assessed internally. In particular, comparison with external supply indicators (e.g., guidelines) is possible.

The findings, which can be embarrassed from clinical databases, support clinical research. With the help of the collected information and its systematic evaluation, new scientific hypotheses can be established. They form the basis for planning and conducting new clinical trials.
Clinical databases are also an important tool for monitoring and evaluating the efficacy, safety and efficacy of performing therapy on non-selected patients. The lack of selection of the patient population in clinical databases also allows conclusions to be drawn about the safety and efficacy of treatment (e.g., surgical procedures) in patients who are often excluded in clinical trials (pregnant women, high-aged patients, adolescents, multimorbid or immunosuppressed patients, etc.).
Clinical databases and registries thus serve to verify the transferability of the results of clinical trials in the daily treatment of unselected patients. An essential part of the database is the information that can be obtained regarding the long-term course of different therapies. This may provide information regarding potentially relevant effect-modifying variables of a treatment. Thus, with the help of clinical registers, subgroups can be identified that are difficult or impossible to appear in randomized clinical trials.

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Organizational Data

  •   DRKS00015005
  •   2018/07/06
  •   [---]*
  •   yes
  •   Approved
  •   217/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Patients with primary or recurrent rectal cancer seeking treatment at the Department of General and Visceral Surgery at the University Medical Center Freiburg will be enrolled.
    The study will include data on primary clinical tumor stage, type, extent and duration of primary therapy (neoadjuvant radio -/chemotherapy or surgery), postoperative pathohistological tumor stage, quality of surgery (e.g. MERCURY), postoperative complications and follow up data regarding tumor-free survival and overall survival.
    Functional outcomes after surgery for rectal cancer will be assessed using the LARS score.
    The data will be collected in a clinical registry. The data facilitate analysis of treatment results, including the surgical quality, at our center. The results might be compared with national and international registries. The results will serve to improve the quality of treatment of patients with rectal cancer.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Establishing a complete registry for patients with primary rectal cancer and recurrent rectal cancer.

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Secondary Outcome

Follow-up on functional results after rectal cancer surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/14
  •   999999
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Primary rectal cancer or
recurrent rectal cancer

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Exclusion Criteria

Cancer not related our the rectum

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Philipp  Manegold 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Philipp  Manegold 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.