Application of ctDNA in the Evaluation of Curative Effect and Prognosis of SCLC Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXiangya Hospital of Central South University
About this trial
The purpose of this study is to evaluate the application value of circulating tumor DNA(ctDNA) with efficacy evaluation and prognostic assessment in patients with unresectable SCLC, who were receiving radiotherapy and chemotherapy treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of informed consent；
Newly diagnosed and histological or cytological confirmed extensive stage small cell lung cancer;
All indicators has confirmed and allow to receive radiotherapy and chemotherapy;
Follow-up can be carried out and the peripheral blood samples can be collected;
Disqualifiers
Patients have other primary cancers;
Patients unable to cooperate with the study for follow-up according to the determined clinical follow-up cycle;
Unable to accept the judgment of curative effect evaluation by the designated methods such as CT.
Trial population
treatment extensive stage small cell lung cancer patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation
Other interventionobserve the association of ctDNA with efficacy of treatment
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
ctDNA mutation profile at baseline
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
Time frame
before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)2
the evolution of ctDNA mutation profile during treatment
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
Time frame
After the first cycle of first line treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)3
the evolution of ctDNA mutation profile during treatment
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
Time frame
After finished the first line treatment, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)Secondary outcomes
1
PFS
Progression free of survival
Time frame
From the first line treatment to the time of disease progression (through study completion, an average of 5 months)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: