An observational study in Pulmonary Nodules, sponsored by AnchorDx Medical Co., Ltd.. Status unknown at 23 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by AnchorDx Medical Co., Ltd. · Observational
Among 43 studies in Multiple Pulmonary Nodules with a site in China — 22 open to participants now, 24 under way, none of them phase 3. Multiple Pulmonary Nodules · China.
Among the 43 studies in Multiple Pulmonary Nodules with a site in China, this one has the largest enrollment of the 22 observational ones that give a count, is one of 4 that started in 2018, is one of 22 observational ones, and was the 3rd registered.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's enrollment of 10,560 is above the median of 255 across 51 observational studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →22 of the 43 studies in Multiple Pulmonary Nodules with a site in China are open now, in 1 country. Each count lists the studies.
Of the 17 Multiple Pulmonary Nodules studies recruiting now, 11 (65%) set no upper age limit and 3 (18%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 4 started in 2018.
Median enrollment 138 across the 21 interventional studies, 450 across the 22 observational. Of the 11 that completed or were terminated, 2 (18%) have results posted.
3 of 43 have an industry lead sponsor. The 10 most frequent:
AnchorDx Medical Co., Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
AnchorDx Medical Co., Ltd. has 2 studies filed under Multiple Pulmonary Nodules — fewer than ten, so there is no comparison to draw.
10 of the studies in Multiple Pulmonary Nodules with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06518655ChromX HealthDifferentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath | 2026-12-30 |
| NCT07595120Shanghai Pulmonary Hospital, Shanghai, ChinaApplication of Electromagnetic Navigation System in Pulmonary Nodule Localization | 2027-01 |
| NCT07719959Peking Union Medical College HospitalA Randomized Controlled Trial of 3D Airway Reconstruction for Precise Double-Lumen Bronchial Intubation | 2027-03 |
| NCT07849400Diansan SuVideo-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery | 2027-03-30 |
| NCT07277088Jiayuan SunThe Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy | 2027-05-30 |
Among the 43 studies in Multiple Pulmonary Nodules with a site in China, from their registry updates:
AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.
This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a prospectively enrolling cohort study and a stratified case-cohort design will be employed to select malignant pulmonary nodules cases and benign pulmonary nodules subjects who will be assayed. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, ctDNA methylation analysis by NGS, at each visit.
Diagnostic Test: ctDNA methylation analysis by NGS
A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Time frame: 3 Years
The diagnostic and monitoring significance of routine tests integrating with ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules
The diagnostic performance of the combination of routine tests and ctDNA methylation analysis by NGS in differentiating benign and malignant pulmonary nodules, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Time frame: 3 Years
Plan to share: No
Started Nov 2018 (actual). Primary completion is estimated for Sep 2024, 70 months after the start.
Of 24 observational studies under Multiple Pulmonary Nodules, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 62. This study's planned 70 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AnchorDx Medical Co., Ltd.