Clinical trial NCT02696525: Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients
Official title: A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Non-small-cell Lung Cancer
Lung Neoplasms
Keywords: Circulating Tumor DNA
Lung cancer
lead time
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: San Valley Biotechnology Incorporated
First posted: 2016-03-02
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed stage ⅢA non-small cell lung cancer patients who have the same driver mutation in tumor tissue and circulating tumor DNA(blood or urine)

Brief summary: Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

Detailed description: Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.

We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 80 years
* Undergo radical surgery（R0 resection）
* Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
* Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
* Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
* Patients must have given written informed consent

Exclusion Criteria:

* Unable to comply with the study procedure
* Malignant tumor history within the past 5 years
* Patients who received any treatment prior to resection
* R1 or R2 resection
* Coexisting small cell lung cancer
* Received target drug therapy after surgery
* Unqualified blood or urine samples

Primary outcomes:
measure: Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
timeFrame: 4 years
Secondary outcomes:
measure: Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers
timeFrame: 4 years
measure: The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample
timeFrame: 1 year
measure: Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis
timeFrame: 4 years
measure: Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis
timeFrame: 4 years
measure: CtDNA predictive value between locoregional recurrence and distant metastasis
timeFrame: 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guang Dong General Hospital, Thoracic Surgery
state: Guangdong
city: Nanjing
country: China
facility: Jiang Su Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Guang Dong General Hospital
name: Yilong Wu, M.D.
role: STUDY_CHAIR
affiliation: Jiang Su Cancer Hospital
name: Lin Xu, M.D.
role: STUDY_DIRECTOR
References: