Basal Cell CancerNCT06894056
Investigating the Effects of Orienting Skin Grafts Parallel to Skin Tension Lines on Quality of Life in Head and Neck Located Basal Cell Carcinoma
An observational study of Basal Cell Cancer and Grafting, run by Sifa Okulu - Independent Research Center of Dermatology and Venereology at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the effect of orienting graft for treatment of skin cancer in patients who undergo skin cancer excision and grafting for their skin cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Basal Cell Cancer, Grafting
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2021to 22 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were selected from the individuals who were admitted or referred to study center (Dr. Hilayda Karakok Private Practice of Dermatology and Venereology).
Who may be able to join
- Patients with nodular basal cell carcinomas with a tumor size equal or less than 12 millimeters
- A history of surgical excision and grafting
Who cannot join
- Immunosuppressed patients
- Recurrent tumors
- Patients with BCC's that arose from the previously irradiated area
- Gorlin's Syndrome diagnosis
- Illiterate individuals
- İmpaired cognitive functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Hilayda Karakök Deri ve Zührevi Hastalıklar Muayenehanesi
Ordu, 52100
About this study
Official title: "Cerrahi Eksizyon ve Greft Ile Tedavi Edilmiş Olan Nonmelanoma Deri Kanseri Hastalarda Greft Donör Alanı Ile Post Operatif 3. Ayda Yaşam Kalitesinin İlişkisinin Araştırılması"
The goal of this observational study is to learn about the effect of orienting graft for treatment of skin cancer in patients who undergo skin cancer excision and grafting for their skin cancer. The main question to answer is
Does orienting the grafts parallel with skin tension lines have any effect on quality of life or cosmetic results?
Participants who already underwent or planned to undergo an excision and grafting procedure will answer a qaulity of life tool and cosmetic results will be evaluated by two seperate dermatologist.
- Conditions
- Basal Cell Cancer, Grafting
- Keywords
- basal cell carcinoma, skin tension lines, grafting, cosmetic outcome, quality of life
- Medical subject headings
- Neoplasms, Basal Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Control patients were selected either from patients with head and neck located BCC's who were treated with excision with grafting harvested from clavicular region with no specific attention in terms of orientation of skin tension lines | |
| Group 2 | Group two was selected from patients with BCC located at head and neck and who underwent a grafting method. A skin tension lines oriented approach was applied and grafts were harvested from a color matched cosmetic area in these patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Outcome
Quality of life outcome was measured by the disease specific tool "Skin Cancer Quality of Life Impact Tool", SCQOLIT is a 10 item questionnaire and each item has 4 answers, total score is ranged between 0-30. Higher scores mean worse outcomes.
Measured: At least three months after surgery and grafting
Quality of Life - General
Dermatology Quality of Life Index was also used to evaluate quality of life as a general quality of life tool. DLQI is alsa a ten item tool with a total score range between 0-30. Higher scores mean worse outcomes.
Measured: At least three months after surgery and grafting
Secondary outcomes (1)
Cosmetic Outcome
Cosmetic outcome of the grafting at the third month, evaluated by two different dermatologists one of whom did the operations. As the initial part of the study was during pandemic precautional period second surgeon the results via photographs (teleconsultation). Visual analog scala is used, the scale is ranged between 0-8, higher scores meaning better outcomes.
Measured: At least three months after the surgery and grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start20 Nov 2021
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell 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-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sifa Okulu - Independent Research Center of Dermatology and Venereology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilayda Karakok Kısla, Sifa Okulu - Independent Research Center of Dermatology and Venereology
- Investigators
- Hilayda Karakök Kışla, MD, Specialist of Dermatology, Principal investigator, Dr. Hilayda Karakök Muayenehanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894056
- Sponsor's protocol ID
- KAEK258
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the sensitivity of the personal information contained within the research data, for the confidentiality and privacy of our participants our team has not yet decided upon sharing. Consequently, while an anonymized version of the data might be shared, individual participant data will not be disclosed to protect their identity and personal information. This approach ensures compliance with ethical standards and regulations related to data privacy.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cerrahi Eksizyon ve Greft Ile Tedavi Edilmiş Olan Nonmelanoma Deri Kanseri Hastalarda Greft Donör Alanı Ile Post Operatif 3. Ayda Yaşam Kalitesinin İlişkisinin Araştırılması"
- ClinicalTrials.gov ID
- NCT06894056
- Acronym / sponsor ID
- KAEK258
- Conditions
- Basal Cell Cancer, Grafting
- Keywords
- basal cell carcinoma, skin tension lines, grafting, cosmetic outcome, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sifa Okulu - Independent Research Center of Dermatology and VenereologyUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 25 Mar 2025 (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 goal of this observational study is to learn about the effect of orienting graft for treatment of skin cancer in patients who undergo skin cancer excision and grafting for their skin cancer. The main question to answer is
Does orienting the grafts parallel with skin tension lines have any effect on quality of life or cosmetic results?
Participants who already underwent or planned to undergo an excision and grafting procedure will answer a qaulity of life tool and cosmetic results will be evaluated by two seperate dermatologist.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Control patients were selected either from patients with head and neck located BCC's who were treated with excision with grafting harvested from clavicular region with no specific attention in terms of orientation of skin tension lines |
| Group 2 | – | –Group two was selected from patients with BCC located at head and neck and who underwent a grafting method. A skin tension lines oriented approach was applied and grafts were harvested from a color matched cosmetic area in these patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were selected from the individuals who were admitted or referred to study center (Dr. Hilayda Karakok Private Practice of Dermatology and Venereology).
Key inclusion criteria (2 listed)
- Patients with nodular basal cell carcinomas with a tumor size equal or less than 12 millimeters
- A history of surgical excision and grafting
Key exclusion criteria (6 listed)
- Immunosuppressed patients
- Recurrent tumors
- Patients with BCC's that arose from the previously irradiated area
- Gorlin's Syndrome diagnosis
- Illiterate individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life Outcome
Time frame: At least three months after surgery and grafting
Quality of life outcome was measured by the disease specific tool "Skin Cancer Quality of Life Impact Tool", SCQOLIT is a 10 item questionnaire and each item has 4 answers, total score is ranged between 0-30. Higher scores mean worse outcomes.
Quality of Life - General
Time frame: At least three months after surgery and grafting
Dermatology Quality of Life Index was also used to evaluate quality of life as a general quality of life tool. DLQI is alsa a ten item tool with a total score range between 0-30. Higher scores mean worse outcomes.
1 secondary outcome
Cosmetic Outcome
Time frame: At least three months after the surgery and grafting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided. Due to the sensitivity of the personal information contained within the research data, for the confidentiality and privacy of our participants our team has not yet decided upon sharing. Consequently, while an anonymized version of the data might be shared, individual participant data will not be disclosed to protect their identity and personal information. This approach ensures compliance with ethical standards and regulations related to data privacy.
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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.
Hilayda Karakök Kışla, MD, Specialist of Dermatology principal investigator
Dr. Hilayda Karakök Muayenehanesi
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 Basal Cell Cancer and Grafting, run by Sifa Okulu - Independent Research Center of Dermatology and Venereology at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 25 Mar 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life Outcome (time frame: At least three months after surgery and grafting). 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?
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 25 Mar 2025.