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MRD Monitoring in Lung Cancer After Resection

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ClinicalTrials.gov Identifier: NCT04976296
Recruitment Status : Not yet recruiting
First Posted : July 26, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Xue-Ning Yang, Guangdong Provincial People's Hospital

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.

Condition or disease Intervention/treatment
Lung Cancer Diagnostic Test: MRD detection

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Molecular Residual Disease Detection in Stage I-IIIA Non-Small Cell Lung Cancer After Radical Resection
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 30, 2027
Estimated Study Completion Date : December 30, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stage I-IIIA NSCLC patients after complete resection
For stage I-IIIA NSCLC patients who underwent complete resection.
Diagnostic Test: MRD detection
The Geneplus OncoMRD lung assay is used to detect the MRD status.
Other Name: Geneplus OncoMRD lung assay




Primary Outcome Measures :
  1. The prognostic value of MRD [ Time Frame: 5 year ]
    The survival difference between MRD positive and MRD negative patients.


Secondary Outcome Measures :
  1. The predictive value of MRD [ Time Frame: 5 year ]
    The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population.

  2. The lead time of MRD [ Time Frame: 5 year ]
    The median lead time of detectable MRD before regular imaging finding.


Biospecimen Retention:   Samples With DNA
Plasma cell free DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976296


Contacts
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Contact: Xue-Ning Yang, Ph.D 020-83827812-51311 yangxuening@gdph.org.cn
Contact: Jia-Tao Zhang, Ph.D 020-83827812-51311 Z18820792959@hotmail.com

Locations
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China, Guangdong
Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510030
Contact: Xue-Ning Yang, Ph.D    020-83827812-51311    yangxuening@gdph.org.cn   
Contact: Jia-Tao Zhang, Ph.D    020-83827812-51311    Z18820792959@hotmail.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Publications:
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Responsible Party: Xue-Ning Yang, Principal Investigator, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04976296    
Other Study ID Numbers: NOTICE study
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The IPD could be shared after seeking consent from the corresponding investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xue-Ning Yang, Guangdong Provincial People's Hospital:
Molecular residual disease
Circulating tumor DNA
Disease relapse
Predictive value
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases