NCT06483919

Brief Summary

This study aims to evaluate the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Brain metastases free survival

    The length of time after the ending of primary treatment that the patient survives without any brain metastases signs or symptoms

    2 years

Secondary Outcomes (1)

  • Overall survival

    2 years

Study Arms (2)

SCLC patients with brain metastasis

SCLC patients without brain metastasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Limited-stage small-cell lung cancer

You may qualify if:

  • Age \> 18 years old
  • Histological / pathologic proved limited-stage small-cell lung cancer
  • Achieved a complete response (CR) or partial response (PR) after first-line CRT

You may not qualify if:

  • Simultaneous participation in another clinical trial
  • Brain MRI was not performed during treatment and follow-up
  • The follow-up time was less than 2 years
  • Patients presenting with other known malignancies for which they are receiving treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Xiangjiao Meng, PhD

    Shandong Cancer Hospital and Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the hospital

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

October 1, 2023

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations

CN(1)