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Status unknownNCT03301961Updated Feb 5, 2020

Multiplex Analysis of Circulating Tumor DNA

An observational study in Carcinoma, Non-small-cell Lung Cancer and Lung Neoplasm, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 101 studies in Carcinoma with a site in China — 37 open to participants now, 49 under way, 12 of them phase 3. Carcinoma · China.

Planned enrollment
7th of 19
400 · median 145
Started
2019
with 6 others
Observational
19 of 101
7 open now
Registered
30th of 101
by date
Lead sponsor
8 of 101
Peking University People's Hospital

Among the 101 studies in Carcinoma with a site in China, this one is the 7th largest by planned enrollment of the 19 observational ones, is one of 7 that started in 2019, is one of 19 observational ones, and was the 30th registered.

By phase

101 studies; the count open now beside each. This study's row is marked.

Phase 226 · 11 open
Phase 320 · 4 open
Observationalthis study19 · 7 open
Phase 112 · 6 open
No phase10 · 4 open
Phase 1/28 · 4 open
Phase 44 · 1 open
Phase 2/32 · 0 open

By the year they started

First in 2006; this study’s year is marked. 7 started in 2019.

Size and results

Median enrollment 72 across the 82 interventional studies, 145 across the 19 observational. Of the 29 that completed or were terminated, 13 (45%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 101 studies in Carcinoma with a site in China, or all of them as a file.
02

Study summary

Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients

Read the detailed description

Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.

Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.

03

Conditions studied

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

Keywords

  • Circulating Tumor DNA
  • Early diagnosis
  • Surveillance
  • Methylation
  • Somatic mutation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

All patient are found nodules in pulmonary and prepare for surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Sign and consent to participate in this study;
  2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion criteria

Exclusion Criteria:

  1. Malignant tumor history within the past 5 years;
  2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
  3. No matching tissue or blood samplesUnqualified blood samples
  4. Lesion is pure ground glass opacity.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer

    Time frame: 12 months

Secondary outcomes

  1. Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer

    Time frame: 12 months

  2. The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection

    Time frame: 36 months

  3. Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
    Recruiting
    • Kezhong Chen, M.D. · Contactmdkzchen@163.com · +8613488752289
    • Jun Wang, M.D. · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2019 (actual). Primary completion is estimated for Jun 2020, 13 months after the start.

Of 50 non-industry observational studies under Carcinoma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 114. This study's planned 13 months is below that.

Counting every sponsor, half of 62 studies reached it within 49 months; a quarter within 29 and three quarters within 166.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2017
First posted
Oct 4, 2017
StartActual
Apr 11, 2019
Primary completionEst.
Jun 1, 2020
CompletionEst.
Jun 1, 2022
Last update
Feb 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03301961
Responsible party
Jun Wang (Chief,Thoracic Surgery Service, Peking University People's Hospital) — Principal investigator
First posted
Oct 4, 2017
Start date
Apr 11, 2019
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Feb 5, 2020

Study contacts

Kezhong Chen, MD
Contact
mdkzchen@163.com
(+86)13488752289
Heng Zhao, MD
Contact
zhaohengzhaoheng@126.com
(+86)13683139396
Kezhong Chen, MD
study director · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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