Brief Summary

The general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. The recruitment will be carried out from July 2023 and will be carried out until December 2023, the analysis of the information will be carried out from January to March 2024.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

553

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach

5 countries

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

July 13, 2023

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

February 6, 2026

Completed

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

August 25, 2023

Results QC Date

December 24, 2025

Last Update Submit

February 5, 2026

Conditions

Lung Cancer Sexual Dysfunction

Keywords

Lung CancerSexual Dysfunction

Outcome Measures

Primary Outcomes (1)

Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction
Identify and describe the type, frequency, and severity of sexual disfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population.
From inclusion up to 3 months

Study Arms (1)

Observational Study Group

* Age greater than or equal to 18 years and less than or equal to 70 years. * Diagnosis of lung cancer stages IB to IV. * Having received systemic oncological treatment for at least 3 months * ECOG ≤ 2

Drug: Systemic oncological treatment

Interventions

Systemic oncological treatmentDRUG

Oncological systemic treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months

Also known as: chemotherapy, radiotherapy

Observational Study Group

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with lung cancer stages IB to IV with ECOG ≤ 2 between 18 and 70 years old that received systemic oncological treatment for at least 3 months.

You may qualify if:

Age greater than or equal to 18 years and less than or equal to 70 years.
Diagnosis of lung cancer stages IB to IV.
Having received systemic oncological treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months with stable tumor disease or partial or complete response in images.
ECOG ≤ 2

You may not qualify if:

Patients with comorbidities (renal failure, cardiovascular diseases or similar) not controlled with corresponding medical management.
Individuals with physical disability or cognitive impairment that prevents them from completing the electronic data collection form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Fundación GECPlead

Study Sites (29)

Instituto Alexander Flemming

Buenos Aires, Buenos Aires, Argentina

Location

Clínica Universitaria Colombia

Bogotá, Bogota D.C., Colombia

Location

Clinica del Occidente

Cali, Cali, Colombia

Location

Hematooncologos SA

Cali, Cali, Colombia

Location

Clínica de Medellín

Medellín, MEdellín, Colombia

Location

Oncomedica, IMAT

Montería, Monteria, Colombia

Location

ALIADAS Instituto Nacional de Enfermedades Neoplasicas

Surquillo, Perú, 15038, Peru

Location

Centro Hospitalar do Porto

Porto, Porto District, 4099-001, Portugal

Location

Hospital General de Elche

Elche, Alicante, 03203, Spain

Location

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Hospital La Mancha Centro

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

Location

Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Infanta Sofia

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, 07198, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

Location

Xarxa sanitaria Santa Tecla- Tarragona

Tarragona, Tarragona, 43003, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Related Publications (1)

Ospina-Serrano AV, Maximiano C, Cantos B, Torrente M, Mendez M, Sanchez JC, Calvo V, Collazo-Lorduy A, Blanco M, Nunez B, Triana I, Parejo C, Martinez P, Duma N, Provencio-Pulla M. Sexual dysfunction in patients with cancer, a challenge in oncology practice: results of the CLARIFY project. Clin Transl Oncol. 2024 May;26(5):1147-1156. doi: 10.1007/s12094-023-03332-0. Epub 2023 Nov 2.
PMID: 37917247RESULT

MeSH Terms

Conditions

Lung NeoplasmsSexual Dysfunction, Physiological

Interventions

Drug TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title: Eva Pereira
Organization: Fundación GECP

Study Officials

Aylen Vanessa Ospina Serrano, MD
Hospital Puerta del Hierro Investigator
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 30, 2023

Study Start

July 13, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

February 6, 2026

Results First Posted

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing: Will not share

Locations

PE(1)PT(1)AR(1)ES(21)CO(5)

Characteristics of Sexual Dysfunction in Patients With Lung Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Observational Study Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Observational Study Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations