Cutaneous Squamous Cell Carcinoma (CSCC)CECRENCT07746258
Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes
A study testing Lymphadenectomy in people with Cutaneous Squamous Cell Carcinoma (CSCC), run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
This study is about a type of skin cancer called high-risk cutaneous squamous cell carcinoma (HRcSCC). Although most people with this type of skin cancer are successfully treated, some patients have a higher chance that the cancer will spread to nearby lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma (CSCC)
- What is being tested?
- Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jul 2014to Apr 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patients with HRcSCC according to the criteria established in the following table.
- Diagnosis of HRcSCC will be made if it complies:
- 3 major criteria
- 2 major criteria and 2 minor criteria
- 1 major criteria and 4 minor criteria.
- Major clinical criteria: Major histological criteria:
Show all 16Show fewer
- Dystrophic epidermolysis ampollosa
- Epidermodysplasia verruciforme
- Congenital dyskeratosis Major tumor thickness of 6 mm.
- Pigmentose xeroderm
- Oculocutaneous albinism
- Immunosuppression by: Perineural invasion Pulmonary transplantation to heart Hematological disease
- Location: lip, anogenital, atrial pavilion Bone infiltration
- Tumor recurrence
- Major tumor diameter of 5 cm.
- Sign informed consent
Who cannot join
- - Presence of clinically obvious metastases (N1)
- Concomitan pathologies with high risk of lethality.
- Concomitan pathologies that contraindicate the test.
- Pregnancy
- Breastfeeding
- T3 or T4 of lip are excluded. These patients will be performed cervical lymphadenectomy by protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Germans Trias i Pujol Universitary Hospital
Badalona, Barcelona, 08916
Antonio Navarro, MSc, +34 93 497 88 65, anavarro@igtp.cat
Maria Del Río, PhD, mariadelriomd@gmail.com
About this study
Official title: Sentinel Lymph Node Biopsy in High-Risk Cutaneous Squamous Cell Carcinoma
This study is about a type of skin cancer called high-risk cutaneous squamous cell carcinoma (HRcSCC). Although most people with this type of skin cancer are successfully treated, some patients have a higher chance that the cancer will spread to nearby lymph nodes. When this happens, treatment becomes more difficult and the chances of recovery are lower.
The aim of this study is to find out whether looking for cancer spread at a very early stage can improve patients' health and survival.
Read more
The study focuses on the sentinel lymph node, which is the first lymph node that fluid from the skin tumour reaches. If cancer cells begin to spread, this is usually the first place where they are found. By examining this lymph node, doctors may be able to detect cancer spread before it can be seen on scans or felt during a physical examination.
A total of 142 participants with high-risk skin cancer who have no signs of cancer spread at the time of diagnosis will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:
Sentinel lymph node biopsy group: Participants will have the usual surgery to remove the skin cancer, together with a small operation to remove the sentinel lymph node. If cancer cells are found in this lymph node, doctors may recommend further treatment, such as surgery to remove additional nearby lymph nodes.
Standard care group: Participants will receive the current standard treatment, which includes surgery to remove skin cancer followed by regular follow-up visits. Further treatment will only be given if there are later signs that the cancer has spread.
Both groups will receive the same regular follow-up care for five years, including medical examinations and imaging tests to check for any signs that the cancer has returned or spread.
Researchers will compare the two groups to determine whether examining the sentinel lymph node helps doctors detect cancer spread earlier, reduces the chance of the cancer returning, and improves long-term survival. The study will also help identify which patients are most likely to benefit from this approach.
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Being tested
- Lymphadenectomy
- Keywords
- Cutaneous squamos Carcinoma, Sentinel nodul
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphadenectomyProcedure or surgery
- Lymphogampigraphy. A planar lymphogampigraphy will be performed, and Single Photon Emission Computed Tomography (SPECT) study if necessary, to study the location of the lymph node or sentinel node. Approximate cutaneous marking with a permanent marker will be performed to facilitate the intraoperative location of the node.
- Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel node. The sentinel node will then be detected with the help of a portable gammagraphic probe. The surgeon will practice a small cutaneous incision through which we will introduce the probe, performing a tracing from more superficial planes to deeper planes. Once located, the sentinel node will be biopsied and is counted on ex vivo radioactivity. In those patients where it is indicated to perform elective cervical lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| early treatment of subclinical metastases | Experimental | Lymphadenectomy will be practiced when the selective biopsy of sentinel node (SBSN) is positive (SBSN +). In patients with T3 or higher N0 and lip carcinoma (since the current protocol indicates performing cervical lymphadenectomy), SBSG will be performed and at the same time of surgery, elective cervical lymphadenectomy. Receives: Procedure: Lymphadenectomy |
| Conventional treatmeng | No intervention | Patients with high risk cutaneous squamous cell carcinoma who do not perform SBSG and do not present N1 at the time of diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time (days) elapsed between diagnosis and death of the patient attributable to the disease before the end of the follow-up period.
Measured: Up to 5 years since intervention
Secondary outcomes (4)
Disease-free time
Disease free time: Time (days) elapsed between the end of treatment and the appearance of disease in the form of local, regional and/or remote recurrence.
Measured: Up to 5 years since intervention
Regional metastases
Clinical and/or radiological presence of adenopathies in the territory of tumor drainage including metastases in transit since intervention to 5 years later
Measured: Up to 5 years since intervention
Remote metastases
clinical and/or radiological presence of metastases outside the lymphatic drainage territory
Measured: Up to 5 years since intervention
Local recurrence
reappearance of the lesion in the same location once treated
Measured: Up to 5 years since intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start25 Jul 2014
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma (CSCC)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746258
- Sponsor's protocol ID
- CECRE
- Acronym
- CECRE
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy in High-Risk Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07746258
- Acronym / sponsor ID
- CECRE / CECRE
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Keywords
- Cutaneous squamos Carcinoma, Sentinel nodul
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Study start
- 25 Jul 2014 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Aug 2026 (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.
This study is about a type of skin cancer called high-risk cutaneous squamous cell carcinoma (HRcSCC). Although most people with this type of skin cancer are successfully treated, some patients have a higher chance that the cancer will spread to nearby lymph nodes. When this happens, treatment becomes more difficult and the chances of recovery are lower.
The aim of this study is to find out whether looking for cancer spread at a very early stage can improve patients' health and survival.
The study focuses on the sentinel lymph node, which is the first lymph node that fluid from the skin tumour reaches. If cancer cells begin to spread, this is usually the first place where they are found. By examining this lymph node, doctors may be able to detect cancer spread before it can be seen on scans or felt during a physical examination.
A total of 142 participants with high-risk skin cancer who have no signs of cancer spread at the time of diagnosis will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:
Sentinel lymph node biopsy group: Participants will have the usual surgery to remove the skin cancer, together with a small operation to remove the sentinel lymph node. If cancer cells are found in this lymph node, doctors may recommend further treatment, such as surgery to remove additional nearby lymph nodes.
Standard care group: Participants will receive the current standard treatment, which includes surgery to remove skin cancer followed by regular follow-up visits. Further treatment will only be given if there are later signs that the cancer has spread.
Both groups will receive the same regular follow-up care for five years, including medical examinations and imaging tests to check for any signs that the cancer has returned or spread.
Researchers will compare the two groups to determine whether examining the sentinel lymph node helps doctors detect cancer spread earlier, reduces the chance of the cancer returning, and improves long-term survival. The study will also help identify which patients are most likely to benefit from this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early treatment of subclinical metastases | Experimental | Procedure: LymphadenectomyLymphadenectomy will be practiced when the selective biopsy of sentinel node (SBSN) is positive (SBSN +). In patients with T3 or higher N0 and lip carcinoma (since the current protocol indicates performing cervical lymphadenectomy), SBSG will be performed and at the same time of surgery, elective cervical lymphadenectomy. |
| Conventional treatmeng | No intervention | –Patients with high risk cutaneous squamous cell carcinoma who do not perform SBSG and do not present N1 at the time of diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with HRcSCC according to the criteria established in the following table.
- 3 major criteria
- 2 major criteria and 2 minor criteria
- 1 major criteria and 4 minor criteria.
- Dystrophic epidermolysis ampollosa
Key exclusion criteria (6 listed)
- - Presence of clinically obvious metastases (N1)
- Concomitan pathologies with high risk of lethality.
- Concomitan pathologies that contraindicate the test.
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| Lymphadenectomy1. Lymphogampigraphy. A planar lymphogampigraphy will be performed, and Single Photon Emission Computed Tomography (SPECT) study if necessary, to study the location of the lymph node or sentinel node. Approximate cutaneous marking with a permanent marker will be performed to facilitate the intraoperative location of the node. 2. Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel node. The sentinel node will then be detected with the help of a portable gammagraphic probe. The surgeon will practice a small cutaneous incision through which we will introduce the probe, performing a tracing from more superficial planes to deeper planes. Once located, the sentinel node will be biopsied and is counted on ex vivo radioactivity. In those patients where it is indicated to perform elective cervical lymphadenectomy. | Procedure or surgery | early treatment of subclinical metastases |
Primary outcome
Overall survival
Time frame: Up to 5 years since intervention
Time (days) elapsed between diagnosis and death of the patient attributable to the disease before the end of the follow-up period.
4 secondary outcomes
Disease-free time
Time frame: Up to 5 years since intervention
Regional metastases
Time frame: Up to 5 years since intervention
Remote metastases
Time frame: Up to 5 years since intervention
Local recurrence
Time frame: Up to 5 years since intervention
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 19 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphadenectomy in people with Cutaneous Squamous Cell Carcinoma (CSCC), run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 16 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 5 years since intervention). 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 19 Aug 2026.