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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Study Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic oncological treatment | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with lung cancer stages IB to IV with ECOG ā¤ 2 between 18 and 70 years old that received systemic oncological treatment for at least 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Aylen Vanessa Ospina Serrano, MD | Hospital Puerta del Hierro Investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Alexander Flemming | Buenos Aires | Buenos Aires | Argentina | |||
| ClĆnica Universitaria Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37917247 | Result | 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. |
| Label | URL |
|---|---|
| Web page of the sponsor where users can find more information about FundaciĆ³n GECP studies | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Study Group |
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2023 |
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| BogotĆ” |
| Bogota D.C. |
| Colombia |
| Clinica del Occidente | Cali | Cali | Colombia |
| Hematooncologos SA | Cali | Cali | Colombia |
| ClĆnica de MedellĆn | MedellĆn | MEdellĆn | Colombia |
| Oncomedica, IMAT | MonterĆa | Monteria | Colombia |
| ALIADAS Instituto Nacional de Enfermedades Neoplasicas | Surquillo | PerĆŗ | 15038 | Peru |
| Centro Hospitalar do Porto | Porto | Porto District | 4099-001 | Portugal |
| Hospital General de Elche | Elche | Alicante | 03203 | Spain |
| ICO Badalona, Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari Vall d' Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital General de Granollers | Granollers | Barcelona | 08402 | Spain |
| Hospital La Mancha Centro | AlcƔzar de San Juan | Ciudad Real | 13600 | Spain |
| Hospital General Universitario de Ciudad Real | Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospitalario Universitario A CoruƱa | A CoruƱa | La CoruƱa | 15006 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | Lugo | 27003 | Spain |
| Hospital de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital ClĆnico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario FundaciĆ³n JimĆ©nez DĆaz | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Infanta Sofia | San SebastiƔn de los Reyes | Madrid | 28702 | Spain |
| Hospital Universitari Son Llatzer | Palma de Mallorca | Palma de Mallorca | 07198 | Spain |
| Hospital ClĆnico de Salamanca | Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Nuestra SeƱora de Candelaria | Santa Cruz de Tenerife | Santa Cruz de Tenerife | 38010 | Spain |
| Xarxa sanitaria Santa Tecla- Tarragona | Tarragona | Tarragona | 43003 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital Universitario La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital ClĆnico Universitario de Valladolid | Valladolid | Valladolid | 47003 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Study Group |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Smoking status | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | From inclusion up to 3 months |
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In this study, adverse events were not collected; therefore, there are no results available
In this study, adverse events were not collected; therefore, there are no results available. Patients affected and patients at risk have been considered as "0" since no data is available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Study Group | In this study, adverse events were not reported; therefore, there are no results available | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Pereira | FundaciĆ³n GECP | +34 934302006 | gecp@gecp.org |
| Feb 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Argentina |
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| Portugal |
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| Never smoker |
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| Unknown |
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| Severe Disturbances in sexual response phases_ Orgasm |
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