Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research

ClinicalTrials.gov ID

NCT02693496

Acronym / sponsor ID

mLOWER / CAALC-002-mLOWER

Conditions

Solitary Pulmonary Nodule

Keywords

ResearchKit, CT screening, Early Diagnosis, Lung Cancer

Study type

Observational

Recruitment status

Unknown status

Enrolment

10,000 participants (estimated)

Lead sponsor

Chinese Alliance Against Lung CancerUniversity, hospital or other

Study start

Oct 2015

Primary completion

Oct 2025 (estimated)

Study completion

Oct 2025 (estimated)

First posted

26 Feb 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.

Study design

Observational model

Cohort

Time perspective

Prospective

Who may qualify

Ages

18 to 90 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Approximately 10,000 patients will participate in this research program, in 100 different medical institutions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. To compare the diagnostic accuracy among different type of lung nodules.

   Time frame: 10 years

   Utilizing the professional statistical software (SPSS 15.0), through T-test, Mann-Whitney U test, and analyzing the receiver operating characteristic (ROC) curve, to compare the diagnostic accuracy among different type of lung nodules. A p<0.05 cutoff will be the standard used to determine statistical significance.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
• Background: PubMed 26331818Yang DW, Zhang Y, Hong QY, Hu J, Li C, Pan BS, Wang Q, Ding FH, Ou JX, Liu FL, Zhang D, Zhou JB, Song YL, Bai CX. Role of a serum-based biomarker panel in the early diagnosis of lung cancer for a cohort of high-risk patients. Cancer. 2015 Sep 1;121 Suppl 17:3113-21. doi: 10.1002/cncr.29551.
• Background: PubMed 23649456Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e93S-e120S. doi: 10.1378/chest.12-2351.
• 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.

34 sites in 1 country: see every site and its status.