Lung CancerLUDICASNCT06018376
Characteristics of Sexual Dysfunction in Patients With Lung Cancer
An observational study of Lung Cancer and Sexual Dysfunction, run by Fundación GECP at 29 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer, Sexual Dysfunction
- What is being tested?
- Systemic oncological treatment
- Type of treatment
- Injection or infusion
- How many people
- 553 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 13 Jul 2023to 29 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
Spain21 sites
Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Hospital La Mancha Centro
Alcázar de San Juan, Ciudad Real, 13600
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Hospital General de Elche
Elche, Alicante, 03203
Hospital de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital General de Granollers
Granollers, Barcelona, 08402
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, 07198
Hospital Clínico de Salamanca
Salamanca, Salamanca, 37007
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
Xarxa sanitaria Santa Tecla- Tarragona
Tarragona, Tarragona, 43003
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Universitario La Fe
Valencia, Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Colombia5 sites
Clínica Universitaria Colombia
Bogotá, Bogota D.C.
Clinica del Occidente
Cali, Cali
Hematooncologos SA
Cali, Cali
Clínica de Medellín
Medellín, MEdellín
Oncomedica, IMAT
Montería, Monteria
Peru1 site
ALIADAS Instituto Nacional de Enfermedades Neoplasicas
Surquillo, Perú, 15038
About this study
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.
Read the detailed description
It is planned to develop a study with a larger number of patients with lung cancer, including the population of Spain and Latin American countries to obtain a sample of more diverse and heterogeneous characteristics, with clinical, cultural, and sociodemographic differences. This will make it possible to obtain better and greater data and therefore define the clinical and treatment factors significantly associated with DS in these individuals and obtain a more complete vision of the reality of the problem.
The results of this research will make it possible to carry out interventions specifically directed at this population and to modify the oncological follow-up guidelines currently in force. Likewise, the information collected will serve as the basis for generating new protocols for a multidisciplinary approach, including the participation of psychology and specialists in urology, gynecology, and psychiatry.
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.
- Conditions
- Lung Cancer, Sexual Dysfunction
- Being tested
- Systemic oncological treatment
- Keywords
- Lung Cancer, Sexual Dysfunction
- Medical subject headings
- Lung Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic oncological treatmentDrug
Also called chemotherapy, radiotherapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Systemic oncological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From inclusion up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start13 Jul 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aylen Vanessa Ospina Serrano, MD, Study chair, Hospital Puerta del Hierro Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018376
- Sponsor's protocol ID
- GECP 23/01_LUDICAS
- Acronym
- LUDICAS
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2023
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37917247
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Sexual Dysfunction in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT06018376
- Acronym / sponsor ID
- LUDICAS / GECP 23/01_LUDICAS
- Conditions
- Lung Cancer, Sexual Dysfunction
- Keywords
- Lung Cancer, Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is planned to develop a study with a larger number of patients with lung cancer, including the population of Spain and Latin American countries to obtain a sample of more diverse and heterogeneous characteristics, with clinical, cultural, and sociodemographic differences. This will make it possible to obtain better and greater data and therefore define the clinical and treatment factors significantly associated with DS in these individuals and obtain a more complete vision of the reality of the problem.
The results of this research will make it possible to carry out interventions specifically directed at this population and to modify the oncological follow-up guidelines currently in force. Likewise, the information collected will serve as the basis for generating new protocols for a multidisciplinary approach, including the participation of psychology and specialists in urology, gynecology, and psychiatry.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Study Group | – | Drug: Systemic oncological treatment* 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic oncological treatmentAlso: chemotherapy, radiotherapyOncological systemic treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months | Drug | Observational Study Group |
Primary outcome
Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction
Time frame: From inclusion up to 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37917247Ospina-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.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aylen Vanessa Ospina Serrano, MD study chair
Hospital Puerta del Hierro Investigator
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Sexual Dysfunction, run by Fundación GECP at 29 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain, Colombia, Argentina, Peru, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction (time frame: From inclusion up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.