Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)
1 other identifier
observational
1,000
1 country
5
Brief Summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1006. In this prospective one-arm observational study, bone scintigraphy will be performed in T1N0M0 NSCLC patients with GGO lesion and other low risk factors of bone metastasis. The occurrence rate of bone metastasis in these patients will be analyzed to evaluate the necessity of bone scintigraphy in cT1N0M0 NSCLC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 28, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJuly 20, 2023
July 1, 2023
2.9 years
September 27, 2018
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients
The Number of cT1N0M0 NSCLC patients that had bone metastasis in this cohort
1 month
Interventions
bone scintigraphy
Eligibility Criteria
cT1N0M0 NSCLC Patients
You may qualify if:
- Patients who sign the informed consent form and are willing to complete the study according to the plan;
- Age 18-80 years old;
- ECOG score ≤ 2 points;
- CT shows that the main lesion is considered to be ground glass nodular lung cancer;
- Preoperative examination CEA \<5ng/ul
- There are no bone related symptoms
- There is no obvious absolute surgical contraindication for preoperative examination.
You may not qualify if:
- History of bone related diseases.
- History of other kinds of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (5)
Anhui Chest Hospital
Hefei, Anhui, 230000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Jiang Du People's Hospital
Yangzhou, Jiangsu, 225200, China
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Jilin Cancer Hospital
Changchun, China
Related Publications (1)
Li H, Ye T, Li N, Xia G, Li B, Zhang Y, Hu H, Sun Y, Zhang Y, Xiang J, Ma D, Weng Y, Liu S, Jia C, Qian B, Gu Y, Li Y, Song S, Chen H. Is 99m Tc bone scintigraphy necessary in the preoperative workup for patients with cT1N0 subsolid lung cancer? A prospective multicenter cohort study. Thorac Cancer. 2021 Feb;12(4):415-419. doi: 10.1111/1759-7714.13752. Epub 2020 Nov 19.
PMID: 33210466DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Haiquan Chen, Ph.D
Shanghai Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 27, 2018
First Posted
September 28, 2018
Study Start
December 1, 2018
Primary Completion
November 1, 2021
Study Completion
November 1, 2022
Last Updated
July 20, 2023
Record last verified: 2023-07