Cutaneous Squamous Cell CarcinomaNCT06046625
Needs and Preferences of Patients With Head-neck Cutaneous SCC
An observational study of Cutaneous Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma
- What is being tested?
- Regular care with additional administration of a semi-structured interview
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, over 18 years of age, clinically diagnosed with a cutaneous squamous cell carcinoma localized in the head and neck area, seen in the MUMC+ at the multidisciplinary head-neck consultation of the department of dermatology, who have already been treated for this cSCC and are willing to participate in the study will be included. If the patient is cognitively unable to participate in the interview, alternatively, a representative may participate in the interview.
Who may be able to join
- Patients diagnosed with a cSCC, located in the head-neck region
- who visited the multidisciplinary head-neck team of the Maastricht University Medical Center+
- who already received treatment for their cSCC
- who gave informed consent for participation
Who cannot join
- patients who are cognitively impaired for participation in an interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Needs and Preferences of Patients With High-risk Cutaneous Squamous Cell Carcinomas in the Head Neck Region: a Qualitative Approach
The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.
Read the detailed description
Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer worldwide after basal cell carcinoma. It involves approximately 20% of all cutaneous malignancies and its incidence is still increasing. In 2020, nearly 15,000 cSCCs were reported in the Netherlands, of which approximately 50% concerned patients aged 75 years or older. UV radiation is the main risk factor for development of a cSCC, therefore the majority of cSCCs are localized to the sun-exposed skin in the head-neck region. cSCCs have a metastatic rate of 2.6-5% and recurrence rate of 1.9-3.7%, with rates increasing in high-risk cSCCs. The increasing incidence, advanced age, the (often) high-risk localization in the head-neck area (given functional and cosmetic importance) and the possible high risk of metastasis result in complex care, especially in stage T2 to T4 cSCCs, also known as high-risk cSCCs.
In this complex care, care pathways offer an excellent opportunity to improve multidisciplinary communication, patient satisfaction, quality and efficiency of care. In this, the experiences and needs of patients are of great importance. Previous research on the experiences and needs of patients with skin cancer is limited and particularly focused on melanomas. In 2017, a qualitative systematic review of the experiences and needs of patients with skin cancer found only two studies examining cSCCs. These studies showed that patients perceived clear information, attention to psychosocial aspects and attention to prevention as important.
In 2019, a study of the needs and experiences of patients with keratinocyte carcinomas, conducted through focus groups, showed similar results. Non of these studies examined cSCCs exclusively, nor did they differentiate by location. However, this appears to be relevant, because of the higher impact on the quality of life of patients with skin cancer in visible locations.
Additionally, studies have been conducted into shared-decision making as part of multidisciplinary care. Complex cases are currently often discussed multidisciplinary. However, several studies describe that such a multidisciplinary approach can impede multidisciplinary decision-making because the patient's perspective is often missing. Studies on the experience of patients with cSCCs in the head neck region are lacking.
- Conditions
- Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Skin Cancer
- Being tested
- Regular care with additional administration of a semi-structured interview
- Keywords
- Patient experience, Patients need, Semi-structured, Professionals, Experience, Needs
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Skin Neoplasms, Patient Satisfaction, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular care with additional administration of a semi-structured interviewOther
Patients receiving regular care. In addition, a semi-structured interview is conducted.
The semi-structured interviews take place once after completion of the care pathway (after all appointments for check-ups associated with the treatment). The interview contains questions about the experience of patients with the care, the needs in this care, the experiences with the information received, the support/guidance, the turnaround time, the treatment received and areas for improvement.
| Study group | Role | What they receive |
|---|---|---|
| Head-neck cutaneous Squamous cell carcinomas | Patients with high risk cutaneous squamous cell carcinoma in the head neck region, receiving regular multidisciplinary care. Receives: Other: Regular care with additional administration of a semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes patients
The emerging themes of patient needs an experiences in the care of cutaneous squamous cell carcinoma in the head-neck region.
Measured: Through study completion, an average of 1 year
Themes professionals
The emerging themes of professionals' needs in the care of patients with cutaneous squamous cell carcinoma in the head-neck area.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Association themes and patient/tumor characteristics
The associations between the emerging themes and baseline characteristics (such as gender, age, marital status, education level, world health organisation performance status, informal care, history of skin cancer, co-occurrence of other skin cancers) and tumor characteristics (such as stage of cSCC, differentiation, type of treatment).
Measured: Through study completion, an average of 1 year
Association themes and professional characteristics
The associations between the emerging themes and characteristics of professionals (gender, age, type of specialty, number of years working as a specialist, number of years of experience within head and neck working group).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2021
- Primary completion1 Nov 2023
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K Mosterd, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046625
- Sponsor's protocol ID
- METC 2021-2765
- Status last verified
- Mar 2025
- First submitted
- 18 Aug 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fania L, Didona D, Di Pietro FR, Verkhovskaia S, Morese R, Paolino G, Donati M, Ricci F, Coco V, Ricci F, Candi E, Abeni D, Dellambra E. Cutaneous Squamous Cell Carcinoma: From Pathophysiology to Novel Therapeutic Approaches. Biomedicines. 2021 Feb 9;9(2):171. doi: 10.3390/biomedicines9020171.
PubMed 33572373Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26.
PubMed 32113941Stern RS; PUVA Follow-Up Study. The risk of squamous cell and basal cell cancer associated with psoralen and ultraviolet A therapy: a 30-year prospective study. J Am Acad Dermatol. 2012 Apr;66(4):553-62. doi: 10.1016/j.jaad.2011.04.004. Epub 2012 Jan 20.
PubMed 22264671Kallini JR, Hamed N, Khachemoune A. Squamous cell carcinoma of the skin: epidemiology, classification, management, and novel trends. Int J Dermatol. 2015 Feb;54(2):130-40. doi: 10.1111/ijd.12553. Epub 2014 Nov 27.
PubMed 25428226Klaus Wolff RAJ, Arturo P. Saavedra, Ellen K. Roh. SECTION 11: PRECANCEROUS LESIONS AND CUTANEOUS CARCINOMAS. Fitzpatrick's Color Atlas and Synopsis of Clinical Dermatology. Eigth edition ed: McGraw-Hill Education; 2017
Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Incidence, risk factors, diagnosis, and staging. J Am Acad Dermatol. 2018 Feb;78(2):237-247. doi: 10.1016/j.jaad.2017.08.059.
PubMed 29332704Mourouzis C, Boynton A, Grant J, Umar T, Wilson A, Macpheson D, Pratt C. Cutaneous head and neck SCCs and risk of nodal metastasis - UK experience. J Craniomaxillofac Surg. 2009 Dec;37(8):443-7. doi: 10.1016/j.jcms.2009.07.007. Epub 2009 Aug 27.
PubMed 19713116Brantsch KD, Meisner C, Schonfisch B, Trilling B, Wehner-Caroli J, Rocken M, Breuninger H. Analysis of risk factors determining prognosis of cutaneous squamous-cell carcinoma: a prospective study. Lancet Oncol. 2008 Aug;9(8):713-20. doi: 10.1016/S1470-2045(08)70178-5. Epub 2008 Jul 9.
PubMed 18617440Brougham ND, Dennett ER, Cameron R, Tan ST. The incidence of metastasis from cutaneous squamous cell carcinoma and the impact of its risk factors. J Surg Oncol. 2012 Dec;106(7):811-5. doi: 10.1002/jso.23155. Epub 2012 May 16.
PubMed 22592943Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study. JAMA Dermatol. 2013 May;149(5):541-7. doi: 10.1001/jamadermatol.2013.2139.
PubMed 23677079Muzic JG, Schmitt AR, Wright AC, Alniemi DT, Zubair AS, Olazagasti Lourido JM, Sosa Seda IM, Weaver AL, Baum CL. Incidence and Trends of Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma: A Population-Based Study in Olmsted County, Minnesota, 2000 to 2010. Mayo Clin Proc. 2017 Jun;92(6):890-898. doi: 10.1016/j.mayocp.2017.02.015. Epub 2017 May 15.
PubMed 28522111van Hoeve JC, Vernooij RWM, Fiander M, Nieboer P, Siesling S, Rotter T. Effects of oncological care pathways in primary and secondary care on patient, professional and health systems outcomes: a systematic review and meta-analysis. Syst Rev. 2020 Oct 25;9(1):246. doi: 10.1186/s13643-020-01498-0.
PubMed 33100227Bath-Hextall F, Nalubega S, Evans C. The needs and experiences of patients with skin cancer: a qualitative systematic review with metasynthesis. Br J Dermatol. 2017 Sep;177(3):666-687. doi: 10.1111/bjd.15148. Epub 2017 Feb 22.
PubMed 27775838Winterbottom A, Harcourt D. Patients' experience of the diagnosis and treatment of skin cancer. J Adv Nurs. 2004 Nov;48(3):226-33. doi: 10.1111/j.1365-2648.2004.03191.x.
PubMed 15488036Bath-Hextall F, Jenkinson C, Kumar A, Leonardi-Bee J, Perkins W, Cox K, Glazebrook C. Longitudinal, mixed method study to look at the experiences and knowledge of non melanoma skin cancer from diagnosis to one year. BMC Dermatol. 2013 Oct 29;13:13. doi: 10.1186/1471-5945-13-13.
PubMed 24164857
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Needs and Preferences of Patients With High-risk Cutaneous Squamous Cell Carcinomas in the Head Neck Region: a Qualitative Approach
- ClinicalTrials.gov ID
- NCT06046625
- Acronym / sponsor ID
- METC 2021-2765
- Conditions
- Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Skin Cancer
- Keywords
- Patient experience, Patients need, Semi-structured, Professionals, Experience, Needs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.
Detailed description
Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer worldwide after basal cell carcinoma. It involves approximately 20% of all cutaneous malignancies and its incidence is still increasing. In 2020, nearly 15,000 cSCCs were reported in the Netherlands, of which approximately 50% concerned patients aged 75 years or older. UV radiation is the main risk factor for development of a cSCC, therefore the majority of cSCCs are localized to the sun-exposed skin in the head-neck region. cSCCs have a metastatic rate of 2.6-5% and recurrence rate of 1.9-3.7%, with rates increasing in high-risk cSCCs. The increasing incidence, advanced age, the (often) high-risk localization in the head-neck area (given functional and cosmetic importance) and the possible high risk of metastasis result in complex care, especially in stage T2 to T4 cSCCs, also known as high-risk cSCCs.
In this complex care, care pathways offer an excellent opportunity to improve multidisciplinary communication, patient satisfaction, quality and efficiency of care. In this, the experiences and needs of patients are of great importance. Previous research on the experiences and needs of patients with skin cancer is limited and particularly focused on melanomas. In 2017, a qualitative systematic review of the experiences and needs of patients with skin cancer found only two studies examining cSCCs. These studies showed that patients perceived clear information, attention to psychosocial aspects and attention to prevention as important.
In 2019, a study of the needs and experiences of patients with keratinocyte carcinomas, conducted through focus groups, showed similar results. Non of these studies examined cSCCs exclusively, nor did they differentiate by location. However, this appears to be relevant, because of the higher impact on the quality of life of patients with skin cancer in visible locations.
Additionally, studies have been conducted into shared-decision making as part of multidisciplinary care. Complex cases are currently often discussed multidisciplinary. However, several studies describe that such a multidisciplinary approach can impede multidisciplinary decision-making because the patient's perspective is often missing. Studies on the experience of patients with cSCCs in the head neck region are lacking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head-neck cutaneous Squamous cell carcinomas | – | Other: Regular care with additional administration of a semi-structured interviewPatients with high risk cutaneous squamous cell carcinoma in the head neck region, receiving regular multidisciplinary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, over 18 years of age, clinically diagnosed with a cutaneous squamous cell carcinoma localized in the head and neck area, seen in the MUMC+ at the multidisciplinary head-neck consultation of the department of dermatology, who have already been treated for this cSCC and are willing to participate in the study will be included. If the patient is cognitively unable to participate in the interview, alternatively, a representative may participate in the interview.
Key inclusion criteria (4 listed)
- Patients diagnosed with a cSCC, located in the head-neck region
- who visited the multidisciplinary head-neck team of the Maastricht University Medical Center+
- who already received treatment for their cSCC
- who gave informed consent for participation
Key exclusion criteria (1 listed)
- patients who are cognitively impaired for participation in an interview
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 |
|---|---|---|
| Regular care with additional administration of a semi-structured interviewPatients receiving regular care. In addition, a semi-structured interview is conducted. The semi-structured interviews take place once after completion of the care pathway (after all appointments for check-ups associated with the treatment). The interview contains questions about the experience of patients with the care, the needs in this care, the experiences with the information received, the support/guidance, the turnaround time, the treatment received and areas for improvement. | Other | Head-neck cutaneous Squamous cell carcinomas |
Primary outcome
Themes patients
Time frame: Through study completion, an average of 1 year
The emerging themes of patient needs an experiences in the care of cutaneous squamous cell carcinoma in the head-neck region.
Themes professionals
Time frame: Through study completion, an average of 1 year
The emerging themes of professionals' needs in the care of patients with cutaneous squamous cell carcinoma in the head-neck area.
2 secondary outcomes
Association themes and patient/tumor characteristics
Time frame: Through study completion, an average of 1 year
Association themes and professional characteristics
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 33572373Fania L, Didona D, Di Pietro FR, Verkhovskaia S, Morese R, Paolino G, Donati M, Ricci F, Coco V, Ricci F, Candi E, Abeni D, Dellambra E. Cutaneous Squamous Cell Carcinoma: From Pathophysiology to Novel Therapeutic Approaches. Biomedicines. 2021 Feb 9;9(2):171. doi: 10.3390/biomedicines9020171.
- Background: PubMed 32113941Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26.
- Background: PubMed 22264671Stern RS; PUVA Follow-Up Study. The risk of squamous cell and basal cell cancer associated with psoralen and ultraviolet A therapy: a 30-year prospective study. J Am Acad Dermatol. 2012 Apr;66(4):553-62. doi: 10.1016/j.jaad.2011.04.004. Epub 2012 Jan 20.
- Background: PubMed 25428226Kallini JR, Hamed N, Khachemoune A. Squamous cell carcinoma of the skin: epidemiology, classification, management, and novel trends. Int J Dermatol. 2015 Feb;54(2):130-40. doi: 10.1111/ijd.12553. Epub 2014 Nov 27.
- BackgroundKlaus Wolff RAJ, Arturo P. Saavedra, Ellen K. Roh. SECTION 11: PRECANCEROUS LESIONS AND CUTANEOUS CARCINOMAS. Fitzpatrick's Color Atlas and Synopsis of Clinical Dermatology. Eigth edition ed: McGraw-Hill Education; 2017
- Background: PubMed 29332704Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Incidence, risk factors, diagnosis, and staging. J Am Acad Dermatol. 2018 Feb;78(2):237-247. doi: 10.1016/j.jaad.2017.08.059.
- Background: PubMed 19713116Mourouzis C, Boynton A, Grant J, Umar T, Wilson A, Macpheson D, Pratt C. Cutaneous head and neck SCCs and risk of nodal metastasis - UK experience. J Craniomaxillofac Surg. 2009 Dec;37(8):443-7. doi: 10.1016/j.jcms.2009.07.007. Epub 2009 Aug 27.
- Background: PubMed 18617440Brantsch KD, Meisner C, Schonfisch B, Trilling B, Wehner-Caroli J, Rocken M, Breuninger H. Analysis of risk factors determining prognosis of cutaneous squamous-cell carcinoma: a prospective study. Lancet Oncol. 2008 Aug;9(8):713-20. doi: 10.1016/S1470-2045(08)70178-5. Epub 2008 Jul 9.
- Background: PubMed 22592943Brougham ND, Dennett ER, Cameron R, Tan ST. The incidence of metastasis from cutaneous squamous cell carcinoma and the impact of its risk factors. J Surg Oncol. 2012 Dec;106(7):811-5. doi: 10.1002/jso.23155. Epub 2012 May 16.
- Background: PubMed 23677079Schmults CD, Karia PS, Carter JB, Han J, Qureshi AA. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study. JAMA Dermatol. 2013 May;149(5):541-7. doi: 10.1001/jamadermatol.2013.2139.
- Background: PubMed 28522111Muzic JG, Schmitt AR, Wright AC, Alniemi DT, Zubair AS, Olazagasti Lourido JM, Sosa Seda IM, Weaver AL, Baum CL. Incidence and Trends of Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma: A Population-Based Study in Olmsted County, Minnesota, 2000 to 2010. Mayo Clin Proc. 2017 Jun;92(6):890-898. doi: 10.1016/j.mayocp.2017.02.015. Epub 2017 May 15.
- Background: PubMed 33100227van Hoeve JC, Vernooij RWM, Fiander M, Nieboer P, Siesling S, Rotter T. Effects of oncological care pathways in primary and secondary care on patient, professional and health systems outcomes: a systematic review and meta-analysis. Syst Rev. 2020 Oct 25;9(1):246. doi: 10.1186/s13643-020-01498-0.
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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.
K Mosterd, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Themes patients (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT06046625, which also lists 19 linked publications.
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 4 Apr 2025.