Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

NCT02965391 | Completed DMC

• 1 other identifier: PTHO1602
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Conditions

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

Keywords

Circulating Tumor DNA; Half time; Lung cancer; Surgery; Surveillance

Outcome Measures

Primary Outcomes (1)

• Half-life of circulating tumor DNA after surgery

  3 months

Secondary Outcomes (3)

• The variation of circulating tumor DNA level before and after surgery

  3 months

• Correlation of circulating tumor DNA level after surgery with tumor recurrence

  3 years

• Correlation of circulating tumor DNA level after surgery with clinical features

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed lung cancer patients who received completely tumor resection

You may qualify if:

• Suspected lung cancer before surgery
• No malignant tumor history within the past 5 years
• The pulmonary nodule is not pure ground glass opacity
• Patients must have given written informed consent

You may not qualify if:

• Multiple primary lung cancer
• R1,R2 resection
• Histology confirmed not non-small cell lung cancer
• Unqualified blood samples

Sponsors & Collaborators

• Peking University People's Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (2)

• Chen K, Zhao H, Shi Y, Yang F, Wang LT, Kang G, Nie Y, Wang J. Perioperative Dynamic Changes in Circulating Tumor DNA in Patients with Lung Cancer (DYNAMIC). Clin Cancer Res. 2019 Dec 1;25(23):7058-7067. doi: 10.1158/1078-0432.CCR-19-1213. Epub 2019 Aug 22.

  PMID: 31439586 DERIVED

• Chen K, Zhao H, Yang F, Hui B, Wang T, Wang LT, Shi Y, Wang J. Dynamic changes of circulating tumour DNA in surgical lung cancer patients: protocol for a prospective observational study. BMJ Open. 2018 Feb 6;8(2):e019012. doi: 10.1136/bmjopen-2017-019012.

  PMID: 29437753 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A series of lung cancer patients plasma before or after surgery.

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jun Wang, M.D.

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

CN (1)