Cutaneous Squamous Cell CarcinomaNCT02672254
New Strategies Against Cutaneous Squamous Cell Carcinoma
An observational study of Cutaneous Squamous Cell Carcinoma, run by Corporacion Parc Tauli.
Trial summary
The gold treatment for local invasive cutaneous squamous cell carcinoma is surgical excision. Nevertheless, surgery is not always an option as a consequence of the age and/or the health status of the patient. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Samples with 2 treatments
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A431NS human squamous cutaneous carcinoma cell line was obtained from the American Type Culture Collection. A431NS cells were cultured in flasks of 25 cm2 with Dulbecco's Modified Eagle's Medium (DMEM) supplemented with 1% penicillin/streptomycin, and with 10% fetal calf serum to reach confluence. Two hundred thousand cells were seeded per well in 24-well plates, and incubated for 24 hours at 37ºC and 5% CO2.
Who may be able to join
- human squamous cutaneous carcinoma cell line
Who cannot join
- contamination
About this study
Official title: Investigation "in Vitro" of New Strategies Alternative to Surgery Against Cutaneous Squamous Cell Carcinoma: Topical Chemotherapy Followed by Superficial Radiotherapy.
The gold treatment for local invasive cutaneous squamous cell carcinoma is surgical excision. Nevertheless, surgery is not always an option as a consequence of the age and/or the health status of the patient. One of the objectives of this study is to assess the effects of cisplatin concomitantly with a subsequent low-energy X-rays irradiation in vitro. In order to enhance the effectiveness of this combined treatment, the temporal fractionation of the platinated compound is expected to be performed.
Read the detailed description
Cutaneous squamous cell carcinoma (cSCC) accounts for the 20% of the most common skin malignancies, i.e. the non-melanoma skin cancer. cSCC is considered one public health problem because of the high costs of its treatment as cSCC are increasing due to a higher sun exposure, as well as more efficient dermatological examinations. In addition, this kind of skin cancer is characterized by a relatively high risk of metastasis.
The gold standard treatment for local invasive cSCC is based on the surgical excision, leading to a 5-years control rate in low-risk patients of 96%. Nevertheless, surgery for local invasive cSCC is not always an option as a consequence of the age and/or the poor health status of the patient. Therefore, ionizing radiation is used as either primary or adjuvant therapy against cSCC in elderly patients or when surgery would be extremely invasive. Although radiotherapy seem to be a promising option, it needs to be improved in order to damage locally the tumor area, thus avoiding damaging secondary effects on healthy tissues. Typical skin radiation sources are based on superficial, orthovoltage X-rays (XR) beams, as well as electron-beam therapy.
In particular, irradiations of local invasive cSCC by using a superficial XR source at kilovoltage (kV) energy permit a local dose deposition within the tumor volume, with a significant smaller penetration capacity with respect to the higher-energy XR sources. Therefore, kV XR sources become a perfect tool for the treatment of superficial lesions, such as the cSCC. The combination of these keV-energy photons with metallic atoms localized in the tumor would enhance the dose deposited locally in the target, improving thus the therapeutic index of the treatment. Among all the chemotherapeutic options available, platinum-based agents, such as cis-diamminedichloroplatinum (II) (cisplatin or cisPt) has become an essential anti-cancer drug with a substantial therapeutic impact against the most carcinomas-like tumors.
The distortion of the structure of the DNA duplex, converts cisPt in a highly toxic agent per se because of its influence on DNA replication, apoptotic death, and inhibition of the major nuclear repair pathway of cisPt-DNA adducts and radiation-induced DNA breaks. However, dose administration is a key limitation due to the high toxicity of this agent. It is for this reason that the lowest cisPt concentration was used in this study, and the expected effectiveness of cisPt on a cSCC cells were enhanced with a subsequent low-energy XR irradiation in an attempt to explore some new therapeutic strategies against local invasive cSCC.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Samples with 2 treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples with 2 treatmentsRadiation
Study the concomitant effects between chemo- and radiotherapy by means of cellular techniques.
| Study group | Role | What they receive |
|---|---|---|
| Shams | Samples without any type of treatment | |
| Samples with 1 treatment | These samples will be treated with only one therapy: chemical agents such as cisplatin or other metallic compounds, or with superficial radiotherapy. These results will help us understand the effectiveness of each treatment by itself on cSCC cells. | |
| Samples with 2 treatments | These samples will be treated with both, chemical agents followed by superficial radiotherapy. These results will provide us information concerning the effectiveness of both treatments, wich is expected to be enhanced by the concomitant effects. Receives: Radiation: Samples with 2 treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the effectiveness of each treatment by means of flow cytometry and transmission electron/photon microscopy
The flow cytometry allows us to analyze the proportion of alive, apoptotic and dead (or necrotic) cells after each treatment, whereas miscroscopy techniques would help us detect cell morphology changes either after chemical agents or X-rays.
Measured: 6 months
Secondary outcomes (1)
Study of the effectiveness of both treatments concomitantly by means of flow cytometry and transmission electron/photon microscopy
The flow cytometry allows us to analyze the proportion of alive, apoptotic and dead (or necrotic) cells after both treatments, whereas miscroscopy techniques would help us detect cell morphology changes (even within the cytoplasm and organelles) after the chemical agents and radiation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies 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
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Silvia Gil Duran, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672254
- Sponsor's protocol ID
- FPT-2016.11
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2016
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation "in Vitro" of New Strategies Alternative to Surgery Against Cutaneous Squamous Cell Carcinoma: Topical Chemotherapy Followed by Superficial Radiotherapy.
- ClinicalTrials.gov ID
- NCT02672254
- Acronym / sponsor ID
- FPT-2016.11
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- 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 gold treatment for local invasive cutaneous squamous cell carcinoma is surgical excision. Nevertheless, surgery is not always an option as a consequence of the age and/or the health status of the patient. One of the objectives of this study is to assess the effects of cisplatin concomitantly with a subsequent low-energy X-rays irradiation in vitro. In order to enhance the effectiveness of this combined treatment, the temporal fractionation of the platinated compound is expected to be performed.
Detailed description
Cutaneous squamous cell carcinoma (cSCC) accounts for the 20% of the most common skin malignancies, i.e. the non-melanoma skin cancer. cSCC is considered one public health problem because of the high costs of its treatment as cSCC are increasing due to a higher sun exposure, as well as more efficient dermatological examinations. In addition, this kind of skin cancer is characterized by a relatively high risk of metastasis.
The gold standard treatment for local invasive cSCC is based on the surgical excision, leading to a 5-years control rate in low-risk patients of 96%. Nevertheless, surgery for local invasive cSCC is not always an option as a consequence of the age and/or the poor health status of the patient. Therefore, ionizing radiation is used as either primary or adjuvant therapy against cSCC in elderly patients or when surgery would be extremely invasive. Although radiotherapy seem to be a promising option, it needs to be improved in order to damage locally the tumor area, thus avoiding damaging secondary effects on healthy tissues. Typical skin radiation sources are based on superficial, orthovoltage X-rays (XR) beams, as well as electron-beam therapy.
In particular, irradiations of local invasive cSCC by using a superficial XR source at kilovoltage (kV) energy permit a local dose deposition within the tumor volume, with a significant smaller penetration capacity with respect to the higher-energy XR sources. Therefore, kV XR sources become a perfect tool for the treatment of superficial lesions, such as the cSCC. The combination of these keV-energy photons with metallic atoms localized in the tumor would enhance the dose deposited locally in the target, improving thus the therapeutic index of the treatment. Among all the chemotherapeutic options available, platinum-based agents, such as cis-diamminedichloroplatinum (II) (cisplatin or cisPt) has become an essential anti-cancer drug with a substantial therapeutic impact against the most carcinomas-like tumors.
The distortion of the structure of the DNA duplex, converts cisPt in a highly toxic agent per se because of its influence on DNA replication, apoptotic death, and inhibition of the major nuclear repair pathway of cisPt-DNA adducts and radiation-induced DNA breaks. However, dose administration is a key limitation due to the high toxicity of this agent. It is for this reason that the lowest cisPt concentration was used in this study, and the expected effectiveness of cisPt on a cSCC cells were enhanced with a subsequent low-energy XR irradiation in an attempt to explore some new therapeutic strategies against local invasive cSCC.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shams | – | –Samples without any type of treatment |
| Samples with 1 treatment | – | –These samples will be treated with only one therapy: chemical agents such as cisplatin or other metallic compounds, or with superficial radiotherapy. These results will help us understand the effectiveness of each treatment by itself on cSCC cells. |
| Samples with 2 treatments | – | Radiation: Samples with 2 treatmentsThese samples will be treated with both, chemical agents followed by superficial radiotherapy. These results will provide us information concerning the effectiveness of both treatments, wich is expected to be enhanced by the concomitant effects. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A431NS human squamous cutaneous carcinoma cell line was obtained from the American Type Culture Collection. A431NS cells were cultured in flasks of 25 cm2 with Dulbecco's Modified Eagle's Medium (DMEM) supplemented with 1% penicillin/streptomycin, and with 10% fetal calf serum to reach confluence. Two hundred thousand cells were seeded per well in 24-well plates, and incubated for 24 hours at 37ºC and 5% CO2.
Key inclusion criteria (1 listed)
- human squamous cutaneous carcinoma cell line
Key exclusion criteria (1 listed)
- contamination
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 |
|---|---|---|
| Samples with 2 treatmentsStudy the concomitant effects between chemo- and radiotherapy by means of cellular techniques. | Radiation | Samples with 2 treatments |
Primary outcome
Study of the effectiveness of each treatment by means of flow cytometry and transmission electron/photon microscopy
Time frame: 6 months
The flow cytometry allows us to analyze the proportion of alive, apoptotic and dead (or necrotic) cells after each treatment, whereas miscroscopy techniques would help us detect cell morphology changes either after chemical agents or X-rays.
1 secondary outcome
Study of the effectiveness of both treatments concomitantly by means of flow cytometry and transmission electron/photon microscopy
Time frame: 6 months
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 3 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma, run by Corporacion Parc Tauli.
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 1 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: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Study of the effectiveness of each treatment by means of flow cytometry and transmission electron/photon microscopy (time frame: 6 months). 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 3 Feb 2016.