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Status unknownNCT03397355Updated Jan 31, 2019

Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.

An observational study in Lung Cancer, sponsored by China-Japan Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by China-Japan Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

In the past few years, circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), microRNAs, autoantibodies, and T-cell receptor repertoire are new biomarkers of liquid biopsy in cancer, which has been demonstrated to have a great value in diagnostics, treatment evaluation, and prognosis prediction. However, most of previous data were based on late stage tumor patients. This study plans to utilize the minimally invasive method to detect the changes of numbers of CTCs, ctDNA hot spot mutations and methylation signals, microRNAs, autoantibodies, and T-cell receptor repertoire in early stage lung cancer patients before and after pulmonary nodule biopsy, during therapeutic and follow-up periods, in order to evaluate the clinical values of above tumor-related biomarkers.

02

Conditions studied

  • Lung Cancer

Keywords

  • Pulmonary Nodule; Lung Cancer; Biopsy; Biomarker.
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with pulmonary nodules (single or multiple) by CT scans.

Inclusion criteria

  • Confirmed as suspected lung cancer patients with pulmonary nodules (single or multiple) by CT scans, and the maximum diameter of nodule is between 8mm and 3cm;
  • Male or female, with age of 18\~80 years;
  • Agree to take the pulmonary nodule biopsy, and sign the Informed Consent.

Exclusion criteria

Exclusion Criteria:

  • With severe comorbidities and unable to participate in this study;
  • Diagnosed with acute respiratory tract infection, for instance fungus, mycobacterium tuberculosis or other bacteria, virus, etc., one month prior to the study recruitment;
  • Pregnant or maternal women;
  • Diagnosed with other carcinoma, and the pulmonary nodules suspected of stemming from other sites;
  • Unable for regular follow-ups according to the research protocol;
  • Blood sample is not qualified for biomarker testing.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Death or survival

    Death or survival

    Time frame: Baseline and every three- or six-month follow-up within two years for each patient.

  2. Disease progress

    Complete Response(CR), Partial Response(PR), Stable Disease(SD), Progressive Disease(PD)

    Time frame: Baseline and every three- or six-month follow-up within two years for each patient.

  3. Reasons of study termination

    Complete the study, Lost to follow-up, Withdrawal of informed consent, Terminated by the investigator, Severe adverse event(SAE).

    Time frame: Baseline and every three- or six-month follow-up within two years for each patient.

06

Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing 100029, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03397355
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Chen Wang (Professor, China-Japan Friendship Hospital) — Principal investigator
First posted
Jan 12, 2018
Start date
Jan 1, 2018
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jan 31, 2019

Study contacts

Jieping LEI, Ph.D.
Contact
jiepinglei@126.com
010-84206408
Sinan WU, M.D.
Contact
tks0423@hotmail.com
010-84206408
Chen WANG, Ph.D.
principal investigator · China-Japan Friendship 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 Jan 2019. You cannot join it, but the record below documents what was studied.

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