Lung CancerNCT04976296
MRD Monitoring in Lung Cancer After Resection
An observational study of Lung Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- MRD detection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The pathological diagnosis confirmed stage I-IIIA NSCLC patients who underwent complete resection. No history of other malignant tumors within 5 years.
Who may be able to join
- 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
Who cannot join
- Mixed small cell and NSCLC histology
- Rx, R1 or R2 resection
- History of other malignant tumors within 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510030
Xue-Ning Yang, Ph.D, 020-83827812-51311, yangxuening@gdph.org.cn
Jia-Tao Zhang, Ph.D, 020-83827812-51311, Z18820792959@hotmail.com
About this study
Official title: Dynamic Molecular Residual Disease Detection in Stage I-IIIA Non-Small Cell Lung Cancer After Radical Resection
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- MRD detection
- Keywords
- Molecular residual disease, Circulating tumor DNA, Disease relapse, Predictive value
- Medical subject headings
- Lung Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD detectionDiagnostic test
Also called Geneplus OncoMRD lung assay
The Geneplus OncoMRD lung assay is used to detect the MRD status.
| Study group | Role | What they receive |
|---|---|---|
| Stage I-IIIA NSCLC patients after complete resection | For stage I-IIIA NSCLC patients who underwent complete resection. Receives: Diagnostic Test: MRD detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognostic value of MRD
The survival difference between MRD positive and MRD negative patients.
Measured: 5 year
Secondary outcomes (2)
The predictive value of MRD
The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population.
Measured: 5 year
The lead time of MRD
The median lead time of detectable MRD before regular imaging finding.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Sep 2021
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue-Ning Yang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976296
- Sponsor's protocol ID
- NOTICE study
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD could be shared after seeking consent from the corresponding investigator.
Publications
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.
PubMed 30796368Abbosh 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.
PubMed 29968853Chaudhuri 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.
PubMed 28899864
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Molecular Residual Disease Detection in Stage I-IIIA Non-Small Cell Lung Cancer After Radical Resection
- ClinicalTrials.gov ID
- NCT04976296
- Acronym / sponsor ID
- NOTICE study
- Conditions
- Lung Cancer
- Keywords
- Molecular residual disease, Circulating tumor DNA, Disease relapse, Predictive value
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage I-IIIA NSCLC patients after complete resection | – | Diagnostic Test: MRD detectionFor stage I-IIIA NSCLC patients who underwent complete resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The pathological diagnosis confirmed stage I-IIIA NSCLC patients who underwent complete resection. No history of other malignant tumors within 5 years.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Mixed small cell and NSCLC histology
- Rx, R1 or R2 resection
- History of other malignant tumors within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRD detectionAlso: Geneplus OncoMRD lung assayThe Geneplus OncoMRD lung assay is used to detect the MRD status. | Diagnostic test | Stage I-IIIA NSCLC patients after complete resection |
Primary outcome
The prognostic value of MRD
Time frame: 5 year
The survival difference between MRD positive and MRD negative patients.
2 secondary outcomes
The predictive value of MRD
Time frame: 5 year
The lead time of MRD
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 30796368Pantel 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.
- Background: PubMed 29968853Abbosh 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.
- Background: PubMed 28899864Chaudhuri 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.
- Individual participant dataSharing planned: Undecided. The IPD could be shared after seeking consent from the corresponding investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue-Ning Yang, Ph.D (020-83827812-51311, yangxuening@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prognostic value of MRD (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04976296, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.