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Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer (ProLung)

1. april 2017 opdateret af: Bai Chunxue, Chinese Alliance Against Lung Cancer

Evaluate the Utility of the ProLung China Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer

A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the diagnosis of lung cancer.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

This Study will assess the stability of the ProLung China Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung China Test when used to evaluate patients with a positive CT scan for lung cancer.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Kina
- Jiangsu
  - Nantong, Jiangsu, Kina, 226000
    - Rekruttering
    - Nantong Tumor Hospital
    - Kontakt:
      
      Xiaodong Zhang, Master
- Shanghai
  - Shanghai, Shanghai, Kina, 200000
    - Rekruttering
    - Zhongshan Hospital of Fudan University
    - Kontakt:
      
      Chunxue Bai, MD
      
      Telefonnummer: 18621170011
      
      E-mail: bai.chunxue@zs-hospital.sh.cn
    - Kontakt:
      
      Dawei Yang, MD
      
      Telefonnummer: 13564703813
      
      E-mail: yang_dw@hotmail.com
  - Shanghai, Shanghai, Kina, 200000
    - Rekruttering
    - Shanghai Dongfang Hospital of Tongji University
    - Kontakt:
      
      Tao Ren, MD
    - Kontakt:
      
      Jingjing Lu, Master
      
      Telefonnummer: 13641791646
      
      E-mail: lujjhf@163.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Subjects with pulmonary lesions suspicious for lung cancer

Beskrivelse

Inclusion Criteria:

Subject is male or female, age 18 to 80.
Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions.
Subject's pulmonary nodule or lesion is greater than 4mm and smaller than 50mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
Subject must be able to receive a ProLung China Test within 30 days of abnormal CT within 14 days prior to the tissue biopsy or surgical resection.

Exclusion Criteria:

Subject has an implanted electronic device in the chest. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules.
Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung China Test or within the previous 14 days for a bronchoscopic procedure.
Subject presents with an anomalous physical or anatomical condition that precludes ProLung China Test measurement.
Subject will have undergone unusually strenuous exercise within 24 hours.
Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Safety and Efficacy of the ProLung China Test Tidsramme: The ProLung China Test will be performed within 30 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.	Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.	The ProLung China Test will be performed within 30 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese Alliance Against Lung Cancer

Efterforskere

Studiestol: Chunxue Bai, MD, Chinese Alliance Against Lung Cancer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2015

Primær færdiggørelse (Forventet)

1. december 2017

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

29. marts 2016

Først indsendt, der opfyldte QC-kriterier