Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes (CECRE)
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.
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona
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Badalona、Barcelona、スペイン、08916
- 募集
- Germans Trias i Pujol Universitary Hospital
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コンタクト：
- Antonio Navarro, MSc
- 電話番号：+34 93 497 88 65
- メール：anavarro@igtp.cat
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コンタクト：
- Maria Del Río, PhD
- メール：mariadelriomd@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
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:
- 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
Exclusion Criteria:
- - 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Conventional treatmeng
Patients with high risk cutaneous squamous cell carcinoma who do not perform SBSG and do not present N1 at the time of diagnosis.
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実験的：early treatment of subclinical metastases
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall survival
時間枠：Up to 5 years since intervention
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Time (days) elapsed between diagnosis and death of the patient attributable to the disease before the end of the follow-up period.
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Up to 5 years since intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease-free time
時間枠：Up to 5 years since intervention
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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.
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Up to 5 years since intervention
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Regional metastases
時間枠：Up to 5 years since intervention
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Clinical and/or radiological presence of adenopathies in the territory of tumor drainage including metastases in transit since intervention to 5 years later
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Up to 5 years since intervention
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Remote metastases
時間枠：Up to 5 years since intervention
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clinical and/or radiological presence of metastases outside the lymphatic drainage territory
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Up to 5 years since intervention
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Local recurrence
時間枠：Up to 5 years since intervention
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reappearance of the lesion in the same location once treated
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Up to 5 years since intervention
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。