Carcinoma of the LungsNCT04960631
Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study
An observational study of Carcinoma of the Lungs, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma of the Lungs
- What is being tested?
- Double site CT guided needle biopsy
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical data of 134 consecutive patients with suspected malignancy who underwent dual site CT guided biopsy in the Third Hospital of Peking University from January 2011 to October 2014
Who may be able to join
- patients with suspected malignancy
- underwent dual site CT guided biopsy in the Third Hospital of Peking University
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.
Read the detailed description
CT guided biopsy is minimally invasive, accurate and low cost. It is often used as an important diagnostic method when the clinical suspect of malignant disease or the treatment effect of the disease is not good. In patients with suspected malignant lung disease, metastasis of other parts of lung, pulmonary door, mediastinum, bone, and distant soft tissue may be combined at the same time. It is the key link of clinical work to evaluate the nature of these coexisting lesions accurately and choose appropriate treatment methods. At present, there is little clinical study on lung centered double site biopsy. This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.
- Conditions
- Carcinoma of the Lungs
- Being tested
- Double site CT guided needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double site CT guided needle biopsyDiagnostic test
Double site CT guided needle biopsy
| Study group | Role | What they receive |
|---|---|---|
| Clinical diagnosis of suspected malignant tumor by dual site CT guided needle biopsy | Not described Receives: Diagnostic Test: Double site CT guided needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
for the combination of two site biopsies
The incidence of 4 kinds of combined pathological results in different lesion location groups was analyzed.
Measured: up to 2weeks
for the combination of two site biopsy approaches 1
The incidence of pneumothorax on the surgical side after unilateral lung biopsy
Measured: up to 2weeks
for the combination of two site biopsy approaches 2
the incidence of pneumothorax on the surgical side after bilateral lung biopsy
Measured: up to 2weeks
for the combination of two site biopsy approaches 3
the incidence of intra tissue hemorrhage after biopsy were statistically analyzed.
Measured: up to 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Mar 2018
- Primary completion30 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of the LungsStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Huishu, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960631
- Sponsor's protocol ID
- M2018060
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study
- ClinicalTrials.gov ID
- NCT04960631
- Acronym / sponsor ID
- M2018060
- Conditions
- Carcinoma of the Lungs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 14 Jul 2021 (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 study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.
Detailed description
CT guided biopsy is minimally invasive, accurate and low cost. It is often used as an important diagnostic method when the clinical suspect of malignant disease or the treatment effect of the disease is not good. In patients with suspected malignant lung disease, metastasis of other parts of lung, pulmonary door, mediastinum, bone, and distant soft tissue may be combined at the same time. It is the key link of clinical work to evaluate the nature of these coexisting lesions accurately and choose appropriate treatment methods. At present, there is little clinical study on lung centered double site biopsy. This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical diagnosis of suspected malignant tumor by dual site CT guided needle biopsy | – | Diagnostic Test: Double site CT guided needle biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical data of 134 consecutive patients with suspected malignancy who underwent dual site CT guided biopsy in the Third Hospital of Peking University from January 2011 to October 2014
Key inclusion criteria (2 listed)
- patients with suspected malignancy
- underwent dual site CT guided biopsy in the Third Hospital of Peking University
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Double site CT guided needle biopsyDouble site CT guided needle biopsy | Diagnostic test | Clinical diagnosis of suspected malignant tumor by dual site CT guided needle biopsy |
Primary outcome
for the combination of two site biopsies
Time frame: up to 2weeks
The incidence of 4 kinds of combined pathological results in different lesion location groups was analyzed.
for the combination of two site biopsy approaches 1
Time frame: up to 2weeks
The incidence of pneumothorax on the surgical side after unilateral lung biopsy
for the combination of two site biopsy approaches 2
Time frame: up to 2weeks
the incidence of pneumothorax on the surgical side after bilateral lung biopsy
for the combination of two site biopsy approaches 3
Time frame: up to 2weeks
the incidence of intra tissue hemorrhage after biopsy were statistically analyzed.
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 14 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Huishu Huishu principal investigator
Peking University Third Hospital
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 Carcinoma of the Lungs, run by Peking University Third 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 2 inclusion and 1 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 14 Jul 2021. 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?
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?
for the combination of two site biopsies (time frame: up to 2weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2021.