Lung NeoplasmsMPSCLCNCT03162705
Molecular Profiling in Small Cell Lung Cancer
An observational study of Lung Neoplasms and Small Cell Lung Cancer, run by Zhujiang Hospital at 1 site in China.
Trial summary
This protocol is to obtain tumor tissues and blood samples from patients with a confirmed histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms, Small Cell Lung Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2017to 31 Dec 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have been histologically diagnosed of small cell lung cancer and evaluated with extensive stage.
Who may be able to join
- Age: between 18 and 75 years old.
- Sexes Eligible for Study: All
- Diagnosed of SCLC by IHC, and divided into extensive stage.
- The ECOG (Eastern Cooperative Oncology Group, ECOG) PS(performance status，PS) Scale score is 0 or 1.
- At least one measurable lesions by CT scan.
- Expect to survive for at least three months.
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- Peripheral blood routine and liver and kidney function meet the following criterion (blood draw 7 days before the treatment begins) :
- The White Blood Cell (WBC) is greater than the 3.0×10^9/L or neutrophils (ANC) more than 1.5 x10^9/L;
- Hemoglobin (HGB) is greater than 80 g/L.
- Platelet (PLT) is greater than 100×10^9/L.
- (AST/ALT): Aspartate aminotransferase/Alanine aminotransferase<3.0 times of normal range.
- Total bilirubin (TBIL) < 1.5 times of normal range.
- Creatinine (CREAT) < 1.5 times of normal range.
- Female or male patients must adopt effective birth control measures.
- Informed consent forms provided. Patients must meet each of the above criteria.
Who cannot join
- Other pathological types of tumors ,rather than small cell lung cancer.
- Incorporating other tumors in the early diagnosis;
- Patients who have received chemotherapy, radiotherapy or any other anti-cancer treatment.
- Patients that known to be allergic to the drug components involved in the study;
- Patients with severe allergies or allergies;
- Pregnant or breastfeeding women;
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- Patients with acute infection which is difficult to control;
- Drug abuse, substance abuse, long-term alcohol and AIDS(Acquired Immune Deficiency Syndrome) patients.
- Candidates who meet each of the exclusion criteria will not included in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, 510282
Qiongyao Wang
Linlang Guo
About this study
Official title: Prospective Molecular Profiling in Small Cell Lung Cancer
This protocol is to obtain tumor tissues and blood samples from patients with a confirmed histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.
Read the detailed description
Small cell lung cancer (SCLC) is most invasive subtypes of lung cancer. After diagnosis, the SCLC patients without treatment often die in 2-4 months. SCLC is a highly heterogeneous malignant tumor, the previous treatment principle of the tumor is based on the traditional histopathology, which not provide accurate guidance for precise treatment. In recent years, breakthrough has been made in molecular classification of breast cancer, non-small cell lung cancer, gastrointestinal cancer and of the other tumor, but SCLC molecular classification has not yet reported.
In this prospective study, SCLC tissues and blood samples from extensive SCLC patients will be obtained and evaluated of molecular profiling. Eligible population includes: patients who have not undergone any treatment and diagnosed of extensive SCLC by immunohistochemistry(IHC). The purpose is to evaluate molecular profiling of SCLC patients who are sensitive or resistant to chemotherapy (Cisplatin+Etoposide). To compare molecular alterations of SCLC patients with different prognosis (Overall Survival, Progress Free Survival).
- Conditions
- Lung Neoplasms, Small Cell Lung Cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
OS is defined as time duration from randomization until the date of death from any cause. If the participants who had survived after the end of the study, or loss of follow-up, their last time of contact is defined as a deadline.
Measured: Five years
Secondary outcomes (1)
Progression-free survival (PFS)
PFS is defined as time duration from randomization until the date of SD(Stable Disease) or PD(Progressed Disease) evaluated by WHO RECIST (World Health Organization Response Evaluation Criteria in Solid Tumors， Edition1.1).
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start3 May 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Linlang Guo, Principal investigator, ZhuJiang Hostipal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162705
- Sponsor's protocol ID
- 2017-BLK-001
- Acronym
- MPSCLC
- Status last verified
- Jan 2019
- First submitted
- 5 May 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lyu Q, Zhu W, Wei T, Ding W, Cao M, Wang Q, Guo L, Luo P, Zhang J. High mutations in fatty acid metabolism contribute to a better prognosis of small-cell lung cancer patients treated with chemotherapy. Cancer Med. 2021 Nov;10(21):7863-7876. doi: 10.1002/cam4.4290. Epub 2021 Sep 26.
PubMed 34564955
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Molecular Profiling in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03162705
- Acronym / sponsor ID
- MPSCLC / 2017-BLK-001
- Conditions
- Lung Neoplasms, Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 3 May 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 May 2017 (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 protocol is to obtain tumor tissues and blood samples from patients with a confirmed histological diagnosis of Small cell lung cancer(SCLC) for molecular profiling.
Detailed description
Small cell lung cancer (SCLC) is most invasive subtypes of lung cancer. After diagnosis, the SCLC patients without treatment often die in 2-4 months. SCLC is a highly heterogeneous malignant tumor, the previous treatment principle of the tumor is based on the traditional histopathology, which not provide accurate guidance for precise treatment. In recent years, breakthrough has been made in molecular classification of breast cancer, non-small cell lung cancer, gastrointestinal cancer and of the other tumor, but SCLC molecular classification has not yet reported.
In this prospective study, SCLC tissues and blood samples from extensive SCLC patients will be obtained and evaluated of molecular profiling. Eligible population includes: patients who have not undergone any treatment and diagnosed of extensive SCLC by immunohistochemistry(IHC). The purpose is to evaluate molecular profiling of SCLC patients who are sensitive or resistant to chemotherapy (Cisplatin+Etoposide). To compare molecular alterations of SCLC patients with different prognosis (Overall Survival, Progress Free Survival).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have been histologically diagnosed of small cell lung cancer and evaluated with extensive stage.
Key inclusion criteria (15 listed)
- Age: between 18 and 75 years old.
- Sexes Eligible for Study: All
- Diagnosed of SCLC by IHC, and divided into extensive stage.
- The ECOG (Eastern Cooperative Oncology Group, ECOG) PS(performance status，PS) Scale score is 0 or 1.
- At least one measurable lesions by CT scan.
Key exclusion criteria (9 listed)
- Other pathological types of tumors ,rather than small cell lung cancer.
- Incorporating other tumors in the early diagnosis;
- Patients who have received chemotherapy, radiotherapy or any other anti-cancer treatment.
- Patients that known to be allergic to the drug components involved in the study;
- Patients with severe allergies or allergies;
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
Overall survival(OS)
Time frame: Five years
OS is defined as time duration from randomization until the date of death from any cause. If the participants who had survived after the end of the study, or loss of follow-up, their last time of contact is defined as a deadline.
1 secondary outcome
Progression-free survival (PFS)
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 34564955Lyu Q, Zhu W, Wei T, Ding W, Cao M, Wang Q, Guo L, Luo P, Zhang J. High mutations in fatty acid metabolism contribute to a better prognosis of small-cell lung cancer patients treated with chemotherapy. Cancer Med. 2021 Nov;10(21):7863-7876. doi: 10.1002/cam4.4290. Epub 2021 Sep 26.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Linlang Guo principal investigator
ZhuJiang Hostipal
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 Neoplasms and Small Cell Lung Cancer, run by Zhujiang 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 15 inclusion and 9 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 22 Jan 2019. 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 Qiongyao Wang (86-13560101028, qiongyaow@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: Five 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 NCT03162705, 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 22 Jan 2019.