Tumor of LungNCT06531850
Prospective Study of Serum Marker LncRNA RP5-977B1 in Pulmonary Nodules
An observational study of Tumor of Lung and Pulmonary Nodule, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
Based on previous studies, this project intends to use prospective studies to select patients identified by imaging as pulmonary nodules to explore the potential of RP5-977B1 in differentiating benign and malignant pulmonary nodules, construct diagnostic models combined with clinical protein tumor markers, compare the… Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Tumor of Lung, Pulmonary Nodule
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 15 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: Serum samples from patients with radiographic findings and surgical removal of pulmonary nodules were selected.
Who may be able to join
- Pulmonary nodules were detected by imaging and surgically resected.
- Age 15-75 years old.
- Surgery or puncture is to be performed for pathological diagnosis.
- Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked.
Who cannot join
- Patient samples have hemolysis, have been contaminated, have been placed for too long, have insufficient sample allowance, and record mixed samples.
- History of malignant tumor. ③ Serious underlying diseases and complications may affect systemic treatment. ④ Can not guarantee to receive blood tests on time. ⑤ Received anti-tumor Chinese medicine, immunization, chemotherapy and other treatments within 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital & Affiliated Guangzhou Medical University
Guangzhou, Guangdong, 510095
Ling Min, Learned, 020-66673666 ext. 3639, minling1977@163.com
About this study
Official title: Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
Based on previous studies, this project intends to use prospective studies to select patients identified by imaging as pulmonary nodules to explore the potential of RP5-977B1 in differentiating benign and malignant pulmonary nodules, construct diagnostic models combined with clinical protein tumor markers, compare the diagnostic efficacy of the two, and finally determine the sensitivity and specificity of markers through pathological results. It provides a new content for the diagnosis of benign and malignant pulmonary nodules.
Read the detailed description
For the purpose of clinical diagnosis, disease monitoring, treatment or prognosis assessment, patients with pulmonary nodules may need to draw blood for routine laboratory tests several times during diagnosis and treatment. There may be some blood samples to be discarded after the completion of routine tests. This clinical trial will only use these remaining blood samples as research samples. The samples collected in this part of the study were serum samples from patients with pulmonary nodules, and 50 subjects were planned to be enrolled.
Admission criteria: ① Pulmonary nodules were detected by imaging and surgically resected.
② Age 15-75 years old.
- Surgery or puncture is to be performed for pathological diagnosis.
- Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked.
Exclusion criteria: ① Patient samples have hemolysis, have been contaminated, have been placed for too long, have insufficient sample allowance, and have mixed records.
- History of malignant tumor.
- Serious underlying diseases and complications may affect systemic treatment. ④ Can not guarantee to receive blood tests on time.
- Received anti-tumor Chinese medicine, immunization, chemotherapy and other treatments within 2 weeks.
Exclusion criteria: ① Subjects who do not meet the inclusion criteria or who meet the exclusion criteria and are mistakenly enrolled.
- Samples collected for two or more times from the same patient should be retained only the samples collected for the first time, and all subsequent samples collected should be excluded.
- Samples with incomplete case information. ④ Sample quality control unqualified samples due to sample collection, storage, transportation and other reasons.
- Samples that cannot be tested due to instruments and other reasons.
- Conditions
- Tumor of Lung, Pulmonary Nodule
- Keywords
- lung cancer; RP5-977B1; LncRNA
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign nodule | * Pulmonary nodules were detected by imaging and surgically resected. * Age 15-75 years old. * Surgery or puncture is to be performed for pathological diagnosis. ④ Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked. | |
| Tumor | * Pulmonary nodules were detected by imaging and surgically resected. * Age 15-75 years old. * Surgery or puncture is to be performed for pathological diagnosis. ④ Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benign nodule
Pathological findings determined that the nodules were benign in the patient
Measured: A week
Tumor
Pathological findings identified the nodules as malignant tumors in the patient
Measured: A week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of LungStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zijian Wu, Learned, Study chair, Cancer Hospital & Affiliated Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531850
- Sponsor's protocol ID
- IIT-2023-013(JYK)
- Status last verified
- Jan 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the requirements of the institution and the need to protect the privacy of patients, it is not convenient to disclose IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
- ClinicalTrials.gov ID
- NCT06531850
- Acronym / sponsor ID
- IIT-2023-013(JYK)
- Conditions
- Tumor of Lung, Pulmonary Nodule
- Keywords
- lung cancer; RP5-977B1; LncRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 1 Aug 2024 (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.
Based on previous studies, this project intends to use prospective studies to select patients identified by imaging as pulmonary nodules to explore the potential of RP5-977B1 in differentiating benign and malignant pulmonary nodules, construct diagnostic models combined with clinical protein tumor markers, compare the diagnostic efficacy of the two, and finally determine the sensitivity and specificity of markers through pathological results. It provides a new content for the diagnosis of benign and malignant pulmonary nodules.
Detailed description
For the purpose of clinical diagnosis, disease monitoring, treatment or prognosis assessment, patients with pulmonary nodules may need to draw blood for routine laboratory tests several times during diagnosis and treatment. There may be some blood samples to be discarded after the completion of routine tests. This clinical trial will only use these remaining blood samples as research samples. The samples collected in this part of the study were serum samples from patients with pulmonary nodules, and 50 subjects were planned to be enrolled.
Admission criteria: ① Pulmonary nodules were detected by imaging and surgically resected.
② Age 15-75 years old.
- Surgery or puncture is to be performed for pathological diagnosis.
- Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked.
Exclusion criteria: ① Patient samples have hemolysis, have been contaminated, have been placed for too long, have insufficient sample allowance, and have mixed records.
- History of malignant tumor.
- Serious underlying diseases and complications may affect systemic treatment. ④ Can not guarantee to receive blood tests on time.
- Received anti-tumor Chinese medicine, immunization, chemotherapy and other treatments within 2 weeks.
Exclusion criteria: ① Subjects who do not meet the inclusion criteria or who meet the exclusion criteria and are mistakenly enrolled.
- Samples collected for two or more times from the same patient should be retained only the samples collected for the first time, and all subsequent samples collected should be excluded.
- Samples with incomplete case information. ④ Sample quality control unqualified samples due to sample collection, storage, transportation and other reasons.
- Samples that cannot be tested due to instruments and other reasons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign nodule | – | –* Pulmonary nodules were detected by imaging and surgically resected. * Age 15-75 years old. * Surgery or puncture is to be performed for pathological diagnosis. ④ Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked. |
| Tumor | – | –* Pulmonary nodules were detected by imaging and surgically resected. * Age 15-75 years old. * Surgery or puncture is to be performed for pathological diagnosis. ④ Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Serum samples from patients with radiographic findings and surgical removal of pulmonary nodules were selected.
Key inclusion criteria (4 listed)
- Pulmonary nodules were detected by imaging and surgically resected.
Key exclusion criteria (2 listed)
- Patient samples have hemolysis, have been contaminated, have been placed for too long, have insufficient sample allowance, and record mixed samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Benign nodule
Time frame: A week
Pathological findings determined that the nodules were benign in the patient
Tumor
Time frame: A week
Pathological findings identified the nodules as malignant tumors in the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No. Due to the requirements of the institution and the need to protect the privacy of patients, it is not convenient to disclose IPD.
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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.
Zijian Wu, Learned study chair
Cancer Hospital & Affiliated Guangzhou Medical University
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 Tumor of Lung and Pulmonary Nodule, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University 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 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zijian Wu, Learned (020-66673666 ext. 3707, 463596459@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benign nodule (time frame: A week). The study lists 2 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 1 Aug 2024.