Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00016416
Date of Registration in DRKS: 2019/04/08
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

Free text: lung cancer nsclc and sclc

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Interventions/Observational Groups

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

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Other
Blinding: Blinded
Who is blinded: patient/subject, investigator/therapist, caregiver, data analyst
Control: Other
Purpose: Prognosis
Assignment: Other
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

Medical Center Klinik für Kardiologie und Pneumologie, Klinikum Esslingen, Esslingen am Neckar

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2019/03/19
Target Sample Size: 180
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Klinik für Kardiologie und Pneumologie, Klinikum Esslingen
- 73730 Esslingen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Institut für Pathologie, Uniklinik Heidelberg
- Mr. Prof. Dr. med. Albrecht Stenzinger
- Germany
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- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Klinik für Kardiologie und PneumologieKlinikum Esslingen
- Mr. Dr. med. Martin Faehling
- Hirschlandstr. 97
- 73730 Esslingen
- Germany
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- Telephone: 0711310382411
- Fax: [---]*
- E-mail: m.faehling at klinikum-esslingen.de
- URL: [---]*
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Contact for Public Queries
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- Klinik für Kardiologie und PneumologieKlinikum Esslingen
- Mr. Dr. med. Martin Faehling
- Hirschlandstr. 97
- 73730 Esslingen
- Germany
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- Telephone: 071131032402
- Fax: [---]*
- E-mail: m.faehling at klinikum-esslingen.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Klinik für Kardiologie und Pneumologie, Klinikum Esslingen
- 73730 Esslingen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

trial protocol (mandatory for transfer to Studybox): Prüfplan
trial protocol (mandatory for transfer to Studybox): Ablaufplan

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