Bone MetastasesNCT03689439
Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)
An observational study of Bone Metastases, run by Fudan University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Metastases
- What is being tested?
- bone scintigraphy
- How many people
- 1,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Dec 2018to 1 Nov 2022
- 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 80 years
- All sexes
- Adult, Older adult
Study population: cT1N0M0 NSCLC Patients
Who may be able to join
- 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.
Who cannot join
- History of bone related diseases.
- History of other kinds of cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Jilin Cancer Hospital
Changchun
Anhui Chest Hospital
Hefei, Anhui, 230000
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
Jiang Du People's Hospital
Yangzhou, Jiangsu, 225200
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer?
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.
Read the detailed description
Skeletal is a common metastatic site in patients with non-small cell lung cancer. The incidence of bone metastases is about 20-30％ in NSCLC patients. According to the NCCN guidelines, early lung cancer patients should also undergo bone scan or PETCT before surgery to determine the presence of bone metastases. However, all of the above methods use radionuclide reagents as tracers, which pose health hazards to patients and their contacts, including medical personnel. A retrospective study conducted by our center showed that only 0.95% of patients with cT1N0M0 non-small cell lung cancer had preoperative bone metastases. In patients with early stage lung cancer whose lesions are pure ground glass nodules, the probability of developing bone metastases is zero. The low risk factors for bone metastases from this retrospective study included preoperative examination of patients with CEA <5 ng/ul and no bone-related symptoms. In patients with primary NSCLC who underwent CEA <5 ng/ul preoperatively, no bone metastases occurred; in patients with negative bone-related symptoms, the incidence of bone metastases was only 0.18%. In the case of such patients, if the bone scan is performed, not only the potential damage to the patient is increased, but also the waste of medical resources and the burden on the patient from the perspective of health economics.
Therefore, our center is expected to conduct this prospective one-arm observational clinical trial. According to the low-risk factors derived from retrospective studies, bone scintigraphy was performed in patients with GGO lesion and other low risk factors of bone metastasis, and the incidence of bone metastasis was obtained. The necessity of bone scintigraphy in cT1N0M0 NSCLC patients would be evaluated.
This trial is recognizes in our institute as "Eastern Cooperative Thoracic Oncology Project (ECTOP-1006)"
- Conditions
- Bone Metastases
- Being tested
- bone scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone scintigraphyDiagnostic test
bone scintigraphy
What is being measured
The primary outcome is the main question the study is designed to answer.
The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients
The Number of cT1N0M0 NSCLC patients that had bone metastasis in this cohort
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Dec 2018
- Primary completion1 Nov 2021
- Study completion1 Nov 2022
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 Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, Ph.D, Principal investigator, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689439
- Sponsor's protocol ID
- ECTOP-1006
- Status last verified
- Jul 2023
- First submitted
- 27 Sep 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33210466
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer?
- ClinicalTrials.gov ID
- NCT03689439
- Acronym / sponsor ID
- ECTOP-1006
- Conditions
- Bone Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 28 Sep 2018 (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 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.
Detailed description
Skeletal is a common metastatic site in patients with non-small cell lung cancer. The incidence of bone metastases is about 20-30％ in NSCLC patients. According to the NCCN guidelines, early lung cancer patients should also undergo bone scan or PETCT before surgery to determine the presence of bone metastases. However, all of the above methods use radionuclide reagents as tracers, which pose health hazards to patients and their contacts, including medical personnel. A retrospective study conducted by our center showed that only 0.95% of patients with cT1N0M0 non-small cell lung cancer had preoperative bone metastases. In patients with early stage lung cancer whose lesions are pure ground glass nodules, the probability of developing bone metastases is zero. The low risk factors for bone metastases from this retrospective study included preoperative examination of patients with CEA <5 ng/ul and no bone-related symptoms. In patients with primary NSCLC who underwent CEA <5 ng/ul preoperatively, no bone metastases occurred; in patients with negative bone-related symptoms, the incidence of bone metastases was only 0.18%. In the case of such patients, if the bone scan is performed, not only the potential damage to the patient is increased, but also the waste of medical resources and the burden on the patient from the perspective of health economics.
Therefore, our center is expected to conduct this prospective one-arm observational clinical trial. According to the low-risk factors derived from retrospective studies, bone scintigraphy was performed in patients with GGO lesion and other low risk factors of bone metastasis, and the incidence of bone metastasis was obtained. The necessity of bone scintigraphy in cT1N0M0 NSCLC patients would be evaluated.
This trial is recognizes in our institute as "Eastern Cooperative Thoracic Oncology Project (ECTOP-1006)"
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- cT1N0M0 NSCLC Patients
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- History of bone related diseases.
- History of other kinds of cancer
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 |
|---|---|---|
| bone scintigraphybone scintigraphy | Diagnostic test | – |
Primary outcome
The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients
Time frame: 1 month
The Number of cT1N0M0 NSCLC patients that had bone metastasis in this cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 33210466Li 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.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Metastases
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
Neoplasm Metastasis / Bone and Bones
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
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.
Haiquan Chen, Ph.D principal investigator
Shanghai Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases, run by Fudan University at 5 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients (time frame: 1 month). 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 NCT03689439, 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 20 Jul 2023.