Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
300 participants
OBSERVATIONAL
2021-04-01
2023-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
NCT05935995
Skin Tumor Biomarkers by Mass Spectrometry Imaging
NCT06227416
Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins
NCT01872130
Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma
NCT06606028
Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck
NCT06744296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Lip carcinomas usually involve squamous cell carcinomas (SCC). In most cases, the SCC is located on the sun-exposed lower lip. In approximately 90% of lower lip SCCs, the tumor is smaller than 2cm in diameter. According to the current eight edition of the Tumor Node Metastasis (TNM) classification of the American Joint Committee on Cancer (AJCC) and the ninth edition of the Union for Internation Cancer Control (UICC), it is classified as tumor stage I.
Surgery is the conventional treatment for a T1 SCC of the lip, where tumor margins can be verified via histologic examination. A histologic margin of less than 2mm is associated with an increased risk of local recurrence and metastasis.
In the Netherlands, surgical treatment of lip carcinomas is performed by dermatologists, plastic and reconstruction surgeons, oral and maxillofacial surgeons (OMFS), and otorhinolaryngologists (ENT). There is currently no international consensus regarding the appropriate surgical margins for excision of a T1 SCC on the lip. According to the AJCC, a surgical margin of 5mm is appropriate, while according to the UICC, a surgical margin of 10mm is appropriate. Scientific evidence is limited regarding differences in tumor clearance and the risk of recurrence or metastasis after excision of T1 SCCs with a surgical margin of 5mm versus 10mm.
We aimed to investigate whether there is a significant difference in tumor-free survival in patients with surgically treated T1 lip SCC with a surgical margin of 5mm versus 10mm.
A retrospective descriptive multicenter data study will be conducted with four different centers in the Netherlands (Maastricht University Medical Center+), Radboud University Medical Center (RadboudUMC) Nijmegen, Catharina Hospital Eindhoven (CZE), and Zuyderland Medical Center Heerlen/Sittard. Data will be obtained from the Dutch Cancer Registry (NKR) and the Dutch Pathological Anatomical National Automated Archive (PALGA).
The primary outcome is the difference in tumor-free survival in patients treated with surgical margins of 5mm and 10mm. The secondary outcome is the difference in tumor-free survival in patients with different histologic free margins. To evaluate the risk of surgical and histologic margins on the risk of local recurrence and metastasis, a Kaplan-Meier analysis, log-rank test and cox-proportional hazard models will be used.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
5mm surgical margin
Patients treated with a 5mm surgical margin for a T1 SCC of the lip.
No interventions assigned to this group
10mm surgical margin
Patients treated with a 10mm surgical margin for a T1 SCC of the lip.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* with a T1 cutaneous squamous cell carcinoma of the lip (including the cutaneous lip, vermillion border, vermillion and mucosal involvement).
* who received surgical treatment
* treated at one of the following centers: Maastricht University Medical Center+ (MUMC+), Radboud University Medical Center (Radboudumc), Zuyderland Medical Center (Zuyderland MC), Catharina Hospital Eindhoven (CZE).
Exclusion Criteria
* Oropharyngeal cancer
* patients with stage T2-T4 cutaneous squamous cell caricnomas of the lip
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maastricht University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
K Mosterd, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radboud UMC
Nijmegen, Gelderland, Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Zuyderland Medical Center
Heerlen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kerawala C, Roques T, Jeannon JP, Bisase B. Oral cavity and lip cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S83-S89. doi: 10.1017/S0022215116000499.
de Visscher JG, Grond AJ, Botke G, van der Waal I. Results of radiotherapy for squamous cell carcinoma of the vermilion border of the lower lip. A retrospective analysis of 108 patients. Radiother Oncol. 1996 Apr;39(1):9-14. doi: 10.1016/0167-8140(96)01716-1.
Kelleners-Smeets NW, Bekkenk MW, de Haas ER. [Skin cancer: from smearing to cutting]. Ned Tijdschr Geneeskd. 2013;157(12):A5602. Dutch.
Biasoli ER, Valente VB, Mantovan B, Collado FU, Neto SC, Sundefeld ML, Miyahara GI, Bernabe DG. Lip Cancer: A Clinicopathological Study and Treatment Outcomes in a 25-Year Experience. J Oral Maxillofac Surg. 2016 Jul;74(7):1360-7. doi: 10.1016/j.joms.2016.01.041. Epub 2016 Jan 30.
de Visscher JG, Gooris PJ, Vermey A, Roodenburg JL. Surgical margins for resection of squamous cell carcinoma of the lower lip. Int J Oral Maxillofac Surg. 2002 Apr;31(2):154-7. doi: 10.1054/ijom.2002.0232.
Joo YH, Cho JK, Koo BS, Kwon M, Kwon SK, Kwon SY, Kim MS, Kim JK, Kim H, Nam I, Roh JL, Park YM, Park IS, Park JJ, Shin SC, Ahn SH, Won S, Ryu CH, Yoon TM, Lee G, Lee DY, Lee MC, Lee JK, Lee JC, Lim JY, Chang JW, Jang JY, Chung MK, Jung YS, Cho JG, Choi YS, Choi JS, Lee GH, Chung PS. Guidelines for the Surgical Management of Oral Cancer: Korean Society of Thyroid-Head and Neck Surgery. Clin Exp Otorhinolaryngol. 2019 May;12(2):107-144. doi: 10.21053/ceo.2018.01816. Epub 2019 Feb 2.
O'Sullivan B. UICC manual of clinical oncology: John Wiley & Sons; 2015.
Related Links
Access external resources that provide additional context or updates about the study.
Integral cancer center Netherlands; incidence rates on lip tumors
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-2224-A-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.