Tunisian Lung Cancer Study | NCT06934499

Studies
Tunisian Lung Cancer Study

NCT06934499

Sponsor

Dacima Consulting

Status

Recruiting

Last Update Posted

Jun 4, 2025Actual

Enrollment

1,334Estimated

Phase

Not provided

Conditions

Pulmonary Cancer

Interventions

Not provided

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2025Actual

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Oct 30, 2026Estimated

First Submitted Date

Apr 11, 2025

First Submission Date that Met QC Criteria

Apr 11, 2025

First Posted Date

Apr 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Dacima ConsultingOTHER

Collaborators

Name	Class
The Multidisciplinary Consultation Meeting Thoracic Oncology of the Abderrahmen Mami Hospital (ROTHAM)	UNKNOWN
Tunisian Society of Respiratory Diseases and Allergology	UNKNOWN
Tunisian Society of Medical Oncology

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, multicenter, observational, national study. Eligible patients will be recruited consecutively among subjects with proven lung cancer, including any disease stage withclinical, therapeutic and evolutive discription.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,334Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic delay	Delay to set the pulmonary cancer diagnosis	Day 1
Survival	Overall survival	12 months
Relapse	Time to relapse	12 months

Secondary Outcomes

Measure	Description	Time Frame
Recommendation Compliance	Compliance to national and international guidance of pulmonary cancer management	Day 1

Other Outcomes

Measure	Description	Time Frame
Multidisciplinary Consultation Meetings	Number of Multidisciplinary Consultation Meetings	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age more than 18 years
Patients receiving health care in the departments of pulmonology, oncology, radiation oncology and thoracic surgery, whose diagnosis is confirmed histologically and/or by cytology, at least 3 months before the inclusion date
Informed consent

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All participants diagnosed with histologically confirmed lung cancer will be included in the study, regardless of sex, age, stage and histological subtype. Patients will be enrolled in the study consecutively The study will be conducted in different regions of Tunisia, encompassing several sites covering different departments in public hospitals.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Soraya Fenniche, MD	Contact	+216 98 586 490		soraya.fenniche@yahoo.fr
Nesrine Mejri, MD	Contact	+216 97 429 933		nesrinemejriturki2@gmail.com

Overall Officials

Name	Affiliation	Role
Soraya Fenniche, MD	Multidisciplinary consultation meeting Thoracic of the Abderrahmen Mami ROTHA Hospital	Study Chair
Nesrine Mejri, MD	Multidisciplinary consultation meeting Thoracic of the Abderrahmen Mami ROTHA Hospital

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tunisian Society of Medical Oncology	Not yet recruiting	Aryanah		2080	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided