NCT04976296

Brief Summary

The conception of molecular residual disease (MRD) extending from hematologic tumor to solid tumors. Evidences supporting MRD evaluation for lung cancer by liquid biopsy has gradually accumulated, especially circulating tumor DNA (ctDNA). In this observational study, the investigators prospectively enroll stage I-IIIA non-small cell lung cancer (NSCLC) patients who underwent complete resection. Preoperative blood sample, tumor tissue and dynamic postoperative blood samples are collected continuously for MRD detection. This study aim to explore the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2021Dec 2027

First Submitted

Initial submission to the registry

July 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

6.3 years

First QC Date

July 19, 2021

Last Update Submit

March 2, 2022

Conditions

Lung Cancer

Keywords

Molecular residual diseaseCirculating tumor DNADisease relapsePredictive value

Outcome Measures

Primary Outcomes (1)

  • The prognostic value of MRD

    The survival difference between MRD positive and MRD negative patients.

    5 year

Secondary Outcomes (2)

  • The predictive value of MRD

    5 year

  • The lead time of MRD

    5 year

Study Arms (1)

Stage I-IIIA NSCLC patients after complete resection

For stage I-IIIA NSCLC patients who underwent complete resection.

Diagnostic Test: MRD detection

Interventions

MRD detectionDIAGNOSTIC_TEST

The Geneplus OncoMRD lung assay is used to detect the MRD status.

Also known as: Geneplus OncoMRD lung assay
Stage I-IIIA NSCLC patients after complete resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The pathological diagnosis confirmed stage I-IIIA NSCLC patients who underwent complete resection. No history of other malignant tumors within 5 years.

You may qualify if:

  • Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage I-IIIA) disease.
  • Complete resection
  • Age ≥18 years at the time of screening
  • Capable of giving signed informed consent

You may not qualify if:

  • Mixed small cell and NSCLC histology
  • Rx, R1 or R2 resection
  • History of other malignant tumors within 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510030, China

RECRUITING

Related Publications (3)

  • Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3.

    PMID: 30796368BACKGROUND

  • Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC - challenges to implementing ctDNA-based screening and MRD detection. Nat Rev Clin Oncol. 2018 Sep;15(9):577-586. doi: 10.1038/s41571-018-0058-3.

    PMID: 29968853BACKGROUND

  • Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.

    PMID: 28899864BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma cell free DNA

MeSH Terms

Conditions

Lung NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xue-Ning Yang, Ph.D

CONTACT

020-83827812-51311yangxuening@gdph.org.cn

Jia-Tao Zhang, Ph.D

CONTACT

020-83827812-51311Z18820792959@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 26, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations

CN(1)