Trial document




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  DRKS00016416

Trial Description

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Title

Prospective evaluation of detection of circulating tumor DNA (ctDNA) to predict recurrence after definitive therapy of localized stage lung cancer (PREDICT)

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Trial Acronym

PREDICT

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Lung cancer patients treated with curative intent with suffer a recurrence in 30 – 80% of cases depending on stage and treatment. At recurrence, curative treatment is generally not possible. Therefore, patients are offered adjuvant therapy aimed at reducing the risk of recurrence. Adjuvant therapy consists of chemotherapy or more recently immuno-oncological treatment. With current diagnostic methods, the individual risk of recurrence cannot be estimated in detail. Therefore, all patients receive adjuvant treatment, even if they might be already cured by the definitive therapy and would not have a recurrence anyway. If these patients, who will not have a recurrence, could be identified prior to adjuvant therapy with a sufficiently accurate diagnostic test, these patients would not require adjuvant therapy. This would reduce morbidity, mortality, and cost. High-sensitivity measurement of pre- and post-therapeutic circulating tumor-DNA (ctDNA) in peripheral blood could provide such a test.
The planned PREDICT study will prospectively non-interventionelly test, whether the measurement of ctDNA is feasible in routine clinical practice, and whether ctDNA accurately predicts the risk of recurrence and survival in a lung cancer population treated with curative intent.

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Organizational Data

  •   DRKS00016416
  •   2019/04/08
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  •   yes
  •   Approved
  •   F-2019-002, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   lung cancer nsclc and sclc
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Interventions/Observational Groups

  •   Based on the ctDNA results, the study population will be analyzed in 3 arms:
    1. ctDNA pre-therapeutically detectable and post-therapeutically not detectable.
  •   2. ctDNA pre-therapeutically detectable und post-therapeutically detectable
  •   3. ctDNA pre-therapeutically not detectable
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, data analyst
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Recurence-free survival at 1, 2, 3, 5 years post-therapeutically.

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Secondary Outcome

Overall-survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/03/19
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with NSCLC stage I-IVA with planned curative therapy. SCLC stage I-IIIC with planned curative therapy.

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Exclusion Criteria

None

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Addresses

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    • Klinik für Kardiologie und Pneumologie, Klinikum Esslingen
    • 73730  Esslingen
    • Germany
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    • Institut für Pathologie, Uniklinik Heidelberg
    • Mr.  Prof. Dr. med.  Albrecht  Stenzinger 
    • Germany
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    • Klinik für Kardiologie und PneumologieKlinikum Esslingen
    • Mr.  Dr. med.  Martin  Faehling 
    • Hirschlandstr. 97
    • 73730  Esslingen
    • Germany
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    • Klinik für Kardiologie und PneumologieKlinikum Esslingen
    • Mr.  Dr. med.  Martin  Faehling 
    • Hirschlandstr. 97
    • 73730  Esslingen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Kardiologie und Pneumologie, Klinikum Esslingen
    • 73730  Esslingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Prüfplan
  •   Ablaufplan
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