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RecruitingNCT05945745Updated Nov 29, 2024

Molecular Analysis and Treatment Options of SCLC

An observational study in Small-cell Lung Cancer, Small Cell Lung Cancer, Combined Type and Small Cell Lung Carcinoma, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Shanghai Chest Hospital · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.

Ongoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.

In summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

02

Conditions studied

  • Small-cell Lung Cancer
  • Small Cell Lung Cancer, Combined Type
  • Small Cell Lung Carcinoma
  • Small Cell Lung Cancer Extensive Stage
  • Small Cell Lung Cancer Limited Stage
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 500 is above the median of 150 across 124 observational studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Participants with SCLC are with the standard treatment and/or are enrolled in the clinical trials.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically proven diagnosis of SCLC
  • 18 years of age or older
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Histologically proven diagnosis of non-SCLC
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • DrugChemotherapy

    different treatments based on the molecular analysis

    Also known as: immunotherapy, targeted therapy

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

  2. Disease control rate (DCR)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

  3. Progression-free survival (PFS)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

Secondary outcomes

  1. Overall survival (OS)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05945745
Responsible party
Xiaomin Niu (Principal Investigator, Shanghai Chest Hospital) — Principal investigator
First posted
Jul 14, 2023
Start date
Jan 1, 2016
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 29, 2024

Study contacts

Xiaomin Niu
Contact
ar_tey@hotmail.com, artey@sjtu.edu.cn
021-22200000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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