Multiple Synchronous Lung Cancers (MSLCs)NCT03795155
Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)
An observational study of Multiple Synchronous Lung Cancers (MSLCs), run by RenJi Hospital at 1 site in China.
Trial summary
This prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for MSLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Synchronous Lung Cancers (MSLCs)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Clinical diagnosis of multiple synchronous lung cancers (MSLCs)
Who may be able to join
- Age 18 years or older
- Confirmed diagnosis of multiple synchronous lung cancers (MSLCs) without metastatic disease
- Signed informed consent
Who cannot join
- Medical or psychiatric condition that would preclude informed consent
- History of known high-risk infections
- With metastatic tumors except lung
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Pengfei Ma, Ph.D., +8613671806647, pengfei0820@163.com
Xiaojing Zhao, M.D.
About this study
This prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for MSLC patients.
Read the detailed description
- To initiate a prospective registry of MSLC patients with high-quality clinical samples and detailed medical data.
- To define the clonal relationship, genomic landscape and potential driver alterations of MSLC using whole-genome sequencing.
- To determine the intrapatient and intratumor genetic heterogeneity of MSLC.
- To correlate molecular features with clinical parameters and patient outcome.
- To serve as a continuous infrastructure for a large variety of research purposes including: A. Diagnostic research B. Prognostic research C. Biological research D. Interventional trial design testing new therapies in MSLC.
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic characters of synchronous lessions in each MSLC patient
Whole-genome sequencing reveals the mutation, copy number variation and structure variation of MSLCs. We will analysis the genomic characters of synchronous lesions in each MSLC patient.
Measured: November 30, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Dec 2018
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Synchronous Lung Cancers (MSLCs)Studies of the same condition, open and under way.
- More trials run by RenJi 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojing Zhao, M.D., Principal investigator, Ren Ji HospitalYujie Fu, Ph.D., Principal investigator, Ren Ji HospitalGuanglei Zhuang, Ph.D., Principal investigator, Ren Ji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795155
- Sponsor's protocol ID
- RenJiH-2018-056
- Status last verified
- Jun 2020
- First submitted
- 2 Jan 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma P, Fu Y, Cai MC, Yan Y, Jing Y, Zhang S, Chen M, Wu J, Shen Y, Zhu L, Chen HZ, Gao WQ, Wang M, Gu Z, Bivona TG, Zhao X, Zhuang G. Simultaneous evolutionary expansion and constraint of genomic heterogeneity in multifocal lung cancer. Nat Commun. 2017 Oct 10;8(1):823. doi: 10.1038/s41467-017-00963-0.
PubMed 29018192
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)
- ClinicalTrials.gov ID
- NCT03795155
- Acronym / sponsor ID
- RenJiH-2018-056
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 7 Jan 2019 (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.
This prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for MSLC patients.
Detailed description
- To initiate a prospective registry of MSLC patients with high-quality clinical samples and detailed medical data.
- To define the clonal relationship, genomic landscape and potential driver alterations of MSLC using whole-genome sequencing.
- To determine the intrapatient and intratumor genetic heterogeneity of MSLC.
- To correlate molecular features with clinical parameters and patient outcome.
- To serve as a continuous infrastructure for a large variety of research purposes including: A. Diagnostic research B. Prognostic research C. Biological research D. Interventional trial design testing new therapies in MSLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of multiple synchronous lung cancers (MSLCs)
Key inclusion criteria (3 listed)
- Age 18 years or older
- Confirmed diagnosis of multiple synchronous lung cancers (MSLCs) without metastatic disease
- Signed informed consent
Key exclusion criteria (3 listed)
- Medical or psychiatric condition that would preclude informed consent
- History of known high-risk infections
- With metastatic tumors except lung
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genomic characters of synchronous lessions in each MSLC patient
Time frame: November 30, 2021
Whole-genome sequencing reveals the mutation, copy number variation and structure variation of MSLCs. We will analysis the genomic characters of synchronous lesions in each MSLC patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Background: PubMed 29018192Ma P, Fu Y, Cai MC, Yan Y, Jing Y, Zhang S, Chen M, Wu J, Shen Y, Zhu L, Chen HZ, Gao WQ, Wang M, Gu Z, Bivona TG, Zhao X, Zhuang G. Simultaneous evolutionary expansion and constraint of genomic heterogeneity in multifocal lung cancer. Nat Commun. 2017 Oct 10;8(1):823. doi: 10.1038/s41467-017-00963-0.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Xiaojing Zhao, M.D. principal investigator
Ren Ji Hospital
Yujie Fu, Ph.D. principal investigator
Ren Ji Hospital
Guanglei Zhuang, Ph.D. principal investigator
Ren Ji Hospital
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 Multiple Synchronous Lung Cancers (MSLCs), run by RenJi 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Ma, Ph.D. (+8613671806647, pengfei0820@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic characters of synchronous lessions in each MSLC patient (time frame: November 30, 2021). 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 NCT03795155, which also lists 1 linked publication.
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 11 Jun 2020.