Lung Cancer Screening by Low Dose CT Scan in a French Department (DEP KP80)

NCT03853967 | Unknown DMC

• 1 other identifier: 160048-B81
• Study Type: interventional
• Target: 1,307
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of cancer death worldwide. The aims of this study were to assess the feasibility and effectiveness of a lung cancer screening pilot program with LD CT scan in a French department (Somme). DEP KP80 was a single-arm, prospective study started in May 2016. The inclusion criteria were those of the National Lung Screening Trial. An annual LD CT scan was scheduled and 2 rounds were planned. Smoking cessation was encouraged as part of the protocol. Subjects were selected by General Practitioner or Pneumologist who checked the inclusion criteria and prescribed the CT scan.

Conditions

Lung Cancer Screening

Keywords

low dose CT scan

Outcome Measures

Primary Outcomes (2)

• feasibility of lung cancer screening implementation in France: participation rate

  number of participants, participation rate : number of LD CT scan performed/ number of participants

  3 years

• efficacity of lung cancer screening in France: number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive

  number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive

  3 years

Study Arms (1)

screening

EXPERIMENTAL

participants performed lung cancer screening by Low Dose CT scan

Other: Low dose CT scan

Interventions

Low dose CT scan OTHER

low dose CT scan

screening

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female
• smokers or former smoker,
• aged between 55 and 74
• tobacco exposure of more than 30 pack-years,
• active smokers or who quitted for less than 15 years,
• obvious symptoms.

You may not qualify if:

• history of cancer within the last 5 years other than non melanoma skin cancer or carcinoma in situ,
• worsening of their health state with Eastern Cooperative Oncology Group performance status\>3,-
• heart or respiratory severe co-morbidity with contraindications to thoracoscopy

Sponsors & Collaborators

• Centre Hospitalier d'Abbeville: lead

Study Sites (1)

LELEU

Abbeville, Somme, 80100, France

RECRUITING

Study Officials

• olivier LELEU

  MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

olivier LELEU

CONTACT

0033322255342; leleu.olivier@ch-abbeville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pneumology department

Model Details: prospective single arm study

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 26, 2019
• Study Start: May 15, 2016
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2021
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

FR (1)