MRD Monitoring in Lung Cancer After Resection

NCT ID: NCT04976296

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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There will be a rapid surge in research about molecular residual disease (MRD) for solid cancer in the near future. However, MRD differed significantly between tumor types and between contexts; there continues to be a considerable lack of awareness and knowledge about using MRD in lung cancer. Hence, this study aims to investigate the value of MRD in NSCLC patients who underwent complete resection. Preoperative blood sample (20ml), tumor tissue and dynamic postoperative blood samples (20ml) are collected continuously for MRD detection. The follow-up was performed once every 3 to 6 months. The primary objective of this study is to assess the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage I-IIIA NSCLC patients after complete resection

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

MRD detection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MRD detection

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Geneplus OncoMRD lung assay

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xue-Ning Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xue-Ning Yang, Ph.D

Role: CONTACT

020-83827812-51311

Jia-Tao Zhang, Ph.D

Role: CONTACT

020-83827812-51311

Facility Contacts

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Xue-Ning Yang, Ph.D

Role: primary

020-83827812-51311

Jia-Tao Zhang, Ph.D

Role: backup

020-83827812-51311

References

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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.

Reference Type BACKGROUND
PMID: 30796368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29968853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28899864 (View on PubMed)

Other Identifiers

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NOTICE study

Identifier Type: -

Identifier Source: org_study_id

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