Derivation and Validation of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

NCT ID: NCT04554875

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-07-01

Brief Summary

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Pulmonary cryptococcosis often manifests as isolated or multiple nodules, easily mimicking lung cancer clinically and radiologically, which ascribes the poor sensitivity of Cryptococcus culture and rarely positive of Cryptococcal antigen test in the absence of disseminated disease. Therefore, the aim of this study was to develop a predictive scoring system from the perspective of available clinical indicators, to differentiate cryptococcosis from adenocarcinoma in pulmonary nodules, which might be beneficial for the delicacy management of pulmonary nodules.

Detailed Description

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Nodule is generally defined as a small, approximately spherical in morphology, circumscribed focus of abnormal tissue on computed tomography (CT) and no greater than 3cm in maximum diameter. Pulmonary nodules are not uncommon. A systematic review of CT screening lung cancer trials noted that a lung nodule was detected in up to 51% of study participants. More than 95% of detected nodules are benign and have a wide variety of causes, including infections, granulomatous disease, hamartomas, arteriovenous malformations, round atelectasis, and lymph nodes.

Pulmonary cryptococcosis is caused by Cryptococcus spp., a ubiquitous budding yeast-like basidiomycete that is endemic in many countries. Previously, Pulmonary cryptococcosis was thought to be an important opportunistic invasive mycosis in immunocompromised patients, such as AIDS, immunosuppressor used after organ transplantation, but it is also common in immunocompetent patients. Pulmonary cryptococcosis often manifests as isolated or multiple nodules, easily mimicking lung cancer clinically and radiologically, which ascribes the poor sensitivity of Cryptococcus culture and rarely positive of Cryptococcal antigen test in the absence of disseminated disease.

Therefore, the aim of this multicenter observational study was to develop a predictive scoring system from the perspective of available clinical indicators, to differentiate cryptococcosis from adenocarcinoma in pulmonary nodules, which might be beneficial for the delicacy management of pulmonary nodules.

Conditions

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Cryptococcosis Lung Adenocarcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Derivation Cohort of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

No interventions assigned to this group

Cohort 2

One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

A scoring system

Intervention Type DIAGNOSTIC_TEST

The scoring system was used to rate score patients.

Cohort 3

One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

A scoring system

Intervention Type DIAGNOSTIC_TEST

The scoring system was used to rate score patients.

Cohort 4

One of Validation Cohorts of a Scoring System to Distinguish Cryptococcosis and Adenocarcinoma in Pulmonary Nodules

A scoring system

Intervention Type DIAGNOSTIC_TEST

The scoring system was used to rate score patients.

Interventions

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A scoring system

The scoring system was used to rate score patients.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with pulmonary nodules
* Evidence of pathological diagnosis for cryptococcosis or adenocarcinoma
* Data on high-resolution computed tomography (HRCT)

Exclusion Criteria

* Pulmonary nodules greater than 3cm in maximum diameter
* Lack of data on HRCT
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Jin-Fu Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-fu Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin-fu Xu, MD

Role: CONTACT

+86 13321922898

Facility Contacts

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Jin-fu Xu, MD

Role: primary

+8613321922898

Other Identifiers

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20200410

Identifier Type: -

Identifier Source: org_study_id

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