Trial document
DRKS00016416
Trial Description
Title
Prospective evaluation of detection of circulating tumor DNA (ctDNA) to predict recurrence after definitive therapy of localized stage lung cancer (PREDICT)
Trial Acronym
PREDICT
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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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
Secondary IDs
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Health Condition or Problem studied
- lung cancer nsclc and sclc
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
Characteristics
- Non-interventional
- Other
- Other
- Blinded
- patient/subject, investigator/therapist, caregiver, data analyst
- Other
- Prognosis
- Other
- N/A
- N/A
Primary Outcome
Recurence-free survival at 1, 2, 3, 5 years post-therapeutically.
Secondary Outcome
Overall-survival
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2019/03/19
- 180
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Patients with NSCLC stage I-IVA with planned curative therapy. SCLC stage I-IIIC with planned curative therapy.
Exclusion Criteria
None
Addresses
-
start of 1:1-Block address primary-sponsor
- 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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end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Klinik für Kardiologie und PneumologieKlinikum Esslingen
- Mr. Dr. med. Martin Faehling
- Hirschlandstr. 97
- 73730 Esslingen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0711310382411
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- m.faehling at klinikum-esslingen.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik für Kardiologie und PneumologieKlinikum Esslingen
- Mr. Dr. med. Martin Faehling
- Hirschlandstr. 97
- 73730 Esslingen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 071131032402
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- m.faehling at klinikum-esslingen.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Klinik für Kardiologie und Pneumologie, Klinikum Esslingen
- 73730 Esslingen
- Germany
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Status
- Recruiting ongoing
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