MalignancyNCT02891642
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
An observational study of Malignancy and Pleural Effusion, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial summary
The purpose of the current study is to establish a Liquid biopsy method (positive enrichment by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous effusions and to evaluate its sensitivity and specificity for clinical application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignancy, Pleural Effusion, Pleural Diseases
- What is being tested?
- Immunomagnetic Detection
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2016to Feb 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with serous effusion.
Who may be able to join
- Males or females >18 years of age;
- Have a serous effusion;
- Scheduled for a diagnostic and/or therapeutic procedure to remove serous fluid ( Puncture of serous cavity).
Who cannot join
- Females known to be pregnant;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjin, Jiangsu, 210029
Jian Xu, MD/PHD, +8602568135230, xu_jian79@163.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Jian Xu, PhD, MD, 86-25-68303453, xu_jian79@163.com
About this study
The purpose of the current study is to establish a Liquid biopsy method (positive enrichment by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous effusions and to evaluate its sensitivity and specificity for clinical application.
Read the detailed description
A serous effusion is common event in metastatic carcinoma, but it also can be associated with other benign medical conditions. Current standard method for detecting malignancy is by cytological examination. However, cytological examination is often low sensitive, often due to the large amount of fluid with relatively sparse tumor cells present and the presence of many normal cells such as mesothelial cell. The investigators have developed a new method, malignant cell enrichment with immunomagnetic beads capture followed by Pap staining and NGS, to identify target malignant cells in body fluids.
McAb NJ001 is developed for malignant cell isolation with immunomagnetic beads capture technique. This is a prospective, multi-center, double-blind, statistically powered clinical trial that will enroll patients scheduled to undergo a procedure for removal of fluid from a serous effusion with or without clinical diagnosis of caner. The purpose of the current study is to compare the novel serous effusion detection assay using NJ001 coated immunomagnetic beads capture followed by Pap staining and NGS analysis with traditional cytologic evaluation.
- Conditions
- Malignancy, Pleural Effusion, Pleural Diseases, Ascites
- Being tested
- Immunomagnetic Detection
- Keywords
- malignancy, Pleural Effusion, Pleural Neoplasms, Ascites
- Medical subject headings
- Neoplasms, Pleural Effusion, Pleural Diseases, Ascites, Pleural Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunomagnetic DetectionDevice
Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.
| Study group | Role | What they receive |
|---|---|---|
| Malignancy, Serous effusion | Analysis of serous effusion through immunomagnetic detection device Receives: Device: Immunomagnetic Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment)
SP70 positive
Measured: The samples will be analyzed within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
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 MalignancyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, M.D. Anderson Cancer Center, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Jiangsu Cancer Institute & Hospital, Anhui Provincial Hospital, Sir Run Run Shaw Hospital, Renmin Hospital of Wuhan University, Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- Shiyang Pan, MD/ PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891642
- Sponsor's protocol ID
- Laboratory Medicine-001
- Status last verified
- Feb 2020
- First submitted
- 26 Aug 2016
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Pan S, Wang F, Huang P, Xu T, Zhang L, Xu J, Li Q, Xia W, Sun R, Huang L, Peng Y, Qin X, Shu Y, Hu Z, Shen H. The study on newly developed McAb NJ001 specific to non-small cell lung cancer and its biological characteristics. PLoS One. 2012;7(3):e33009. doi: 10.1371/journal.pone.0033009. Epub 2012 Mar 30.
PubMed 22479355
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
- ClinicalTrials.gov ID
- NCT02891642
- Acronym / sponsor ID
- Laboratory Medicine-001
- Conditions
- Malignancy, Pleural Effusion, Pleural Diseases, Ascites
- Keywords
- malignancy, Pleural Effusion, Pleural Neoplasms, Ascites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, M.D. Anderson Cancer Center, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Jiangsu Cancer Institute & Hospital, Anhui Provincial Hospital, Sir Run Run Shaw Hospital, Renmin Hospital of Wuhan University, Xuanwu Hospital, Beijing
- Study start
- Sep 2016
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- 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.
The purpose of the current study is to establish a Liquid biopsy method (positive enrichment by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous effusions and to evaluate its sensitivity and specificity for clinical application.
Detailed description
A serous effusion is common event in metastatic carcinoma, but it also can be associated with other benign medical conditions. Current standard method for detecting malignancy is by cytological examination. However, cytological examination is often low sensitive, often due to the large amount of fluid with relatively sparse tumor cells present and the presence of many normal cells such as mesothelial cell. The investigators have developed a new method, malignant cell enrichment with immunomagnetic beads capture followed by Pap staining and NGS, to identify target malignant cells in body fluids.
McAb NJ001 is developed for malignant cell isolation with immunomagnetic beads capture technique. This is a prospective, multi-center, double-blind, statistically powered clinical trial that will enroll patients scheduled to undergo a procedure for removal of fluid from a serous effusion with or without clinical diagnosis of caner. The purpose of the current study is to compare the novel serous effusion detection assay using NJ001 coated immunomagnetic beads capture followed by Pap staining and NGS analysis with traditional cytologic evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malignancy, Serous effusion | – | Device: Immunomagnetic DetectionAnalysis of serous effusion through immunomagnetic detection device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with serous effusion.
Key inclusion criteria (3 listed)
- Males or females >18 years of age;
- Have a serous effusion;
- Scheduled for a diagnostic and/or therapeutic procedure to remove serous fluid ( Puncture of serous cavity).
Key exclusion criteria (1 listed)
- Females known to be pregnant;
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 |
|---|---|---|
| Immunomagnetic DetectionImmunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques. | Device | Malignancy, Serous effusion |
Primary outcome
Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment)
Time frame: The samples will be analyzed within 18 months
SP70 positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Background: PubMed 22479355Pan S, Wang F, Huang P, Xu T, Zhang L, Xu J, Li Q, Xia W, Sun R, Huang L, Peng Y, Qin X, Shu Y, Hu Z, Shen H. The study on newly developed McAb NJ001 specific to non-small cell lung cancer and its biological characteristics. PLoS One. 2012;7(3):e33009. doi: 10.1371/journal.pone.0033009. Epub 2012 Mar 30.
- Individual participant dataSharing planned: Undecided
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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.
Shiyang Pan, MD/ PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignancy and Pleural Effusion, run by The First Affiliated Hospital with Nanjing Medical University at 2 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 3 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Xu, MD/ PhD (+8602568135230, xu_jian79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment) (time frame: The samples will be analyzed within 18 months). 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 NCT02891642, 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 6 Feb 2020.