CClinicalTrials.gg
Status unknownNCT02696525Updated May 21, 2018

Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

An observational study in Carcinoma, Non-small-cell Lung Cancer and Lung Neoplasms, sponsored by Peking University People's Hospital. Status unknown at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
145
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Carcinoma
  • Non-small-cell Lung Cancer
  • Lung Neoplasms

Keywords

  • Circulating Tumor DNA
  • Lung cancer
  • lead time
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 145 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
145 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches

    Time frame: 4 years

Secondary outcomes

  1. Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers

    Time frame: 4 years

  2. The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample

    Time frame: 1 year

  3. Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis

    Time frame: 4 years

  4. Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis

    Time frame: 4 years

  5. CtDNA predictive value between locoregional recurrence and distant metastasis

    Time frame: 4 years

07

Study locations

3 sites
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
    • Kezhong Chen, M.D. · Contact · mdkzchen@163.com · +8613488752289
    • Lixin Zhou, M.D. · Contact · zhoulixin04@sina.com · +8613811264336
    • Jun Wang, M.D. · Principal investigator
    • Fan Yang, M.D. · Sub investigator
    • Kezhong Chen, M.D. · Sub investigator
    • Lixin Zhou, M.D. · Sub investigator
  • Guang Dong General Hospital, Thoracic Surgery
    Guangzhou, Guangdong 510080, China
    • Xuening Yang, M.D. · Contact
    • Wenzhao Zhong, M.D. · Contact
    • Yilong Wu, M.D. · Principal investigator
    • Xuening Yang, M.D. · Sub investigator
    • Wenzhao Zhong, M.D. · Sub investigator
  • Jiang Su Cancer Hospital
    Nanjing, Jiangsu 210009, China
    • Feng Yin, M.D. · Contact
    • Lin Xu, M.D. · Principal investigator
    • Feng Yin, M.D. · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02696525
Lead sponsor
Peking University People's Hospital
Collaborators
San Valley Biotechnology Incorporated
Responsible party
Jun Wang (Chief,Thoracic Surgery Service, Peking University People's Hospital) — Principal investigator
First posted
Mar 2, 2016
Start date
Dec 2018 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
May 21, 2018

Study contacts

Kezhong Chen, M.D.
Contact
mdkzchen@163.com
(+86)13488752289
Lixin Zhou, M.D.
Contact
zhoulixin04@sina.com
(+86)13811264336
Jun Wang, M.D.
principal investigator · Peking University People's Hospital
Yilong Wu, M.D.
study chair · Guang Dong General Hospital
Lin Xu, M.D.
study director · Jiang Su Cancer Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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