Lung CancerLCLCNCT02917369
Integrative Analysis of Large-cell Lung Cancer
An observational study of Lung Cancer, run by Shanghai 10th People's Hospital at 3 sites in China.
Trial summary
Integrative analysis of LCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Normal lung tissue
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2016to Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with large-cell lung cancer
Who may be able to join
- Age ≤ 75 years with histologically proven LCLC
- No severe major organ dysfunction
- World Health Organization (WHO) performance status of 0 or 1
- No prior cancer chemotherapy
Who cannot join
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Ganzhou City People's Hospital
Ganzhou, Jiangxi, 341000
Xiaoming Zhong, MD, 00-86-797-8356156, 15979192617@163.com
Xiaoming Zhong, MD
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Da Fu, PhD, 00-86-21-66301604, fu800da900@126.com
Yushui Ma, PhD
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Likun Hou, MD, 00-86-21-65115006 ext. 3030, hlk9575@163.com
Likun Hou, MD
About this study
Official title: Integrative Analysis of Large-cell Lung Carcinoma
Integrative analysis of LCLC
Read the detailed description
The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.
- Conditions
- Lung Cancer
- Being tested
- Normal lung tissue
- Keywords
- LCLC; Integrative Analysis; Metastasis
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal lung tissueOther
The investigators will extract total protein, DNA and RNA from LCLC patients.
| Study group | Role | What they receive |
|---|---|---|
| Normal lung tissue | Normal lung tissue from LCLC patients Receives: Other: Normal lung tissue | |
| LCLC tissues | LCLC tissues from LCLC patients Receives: Other: Normal lung tissue | |
| Metastasis tissues | Metastasis tissues from LCLC patients Receives: Other: Normal lung tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years overall survival
Measured: 5 years
Secondary outcomes (1)
5 years disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Lung CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Principal investigator, Da Fu, Shanghai 10th People's Hospital
- Investigators
- Da Fu, PhD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917369
- Sponsor's protocol ID
- 2016-52-Rainy
- Acronym
- LCLC
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators are willing to share data.
Publications
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Analysis of Large-cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT02917369
- Acronym / sponsor ID
- LCLC / 2016-52-Rainy
- Conditions
- Lung Cancer
- Keywords
- LCLC; Integrative Analysis; Metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- Jan 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- 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.
Integrative analysis of LCLC
Detailed description
The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal lung tissue | – | Other: Normal lung tissueNormal lung tissue from LCLC patients |
| LCLC tissues | – | Other: Normal lung tissueLCLC tissues from LCLC patients |
| Metastasis tissues | – | Other: Normal lung tissueMetastasis tissues from LCLC patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with large-cell lung cancer
Key inclusion criteria (4 listed)
- Age ≤ 75 years with histologically proven LCLC
- No severe major organ dysfunction
- World Health Organization (WHO) performance status of 0 or 1
- No prior cancer chemotherapy
Key exclusion criteria (4 listed)
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
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 |
|---|---|---|
| Normal lung tissueThe investigators will extract total protein, DNA and RNA from LCLC patients. | Other | LCLC tissues, Metastasis tissues, Normal lung tissue |
Primary outcome
5 years overall survival
Time frame: 5 years
1 secondary outcome
5 years disease-free survival
Time frame: 5 years
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 28 Sep 2016.
- Results publication: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Individual participant dataSharing planned: Yes. The investigators are willing to share data.
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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.
Da Fu, PhD principal investigator
Shanghai 10th People's Hospital
3 sites 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 Shanghai 10th People's Hospital at 3 sites 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 4 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Da Fu, PhD (00-86-21-66301604, fu800da900@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years overall survival (time frame: 5 years). 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 NCT02917369, 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 28 Sep 2016.