Clinical Diagnosis of Basal Cell Carcinoma Subtype

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01370824
First received: June 7, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the suspected lesion, in order to determine the subtype of BCC. There are three different histological subtypes of BCC, from least to most aggressive: superficial, nodular and aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes according to the Dutch guidelines. Recent developments of non-invasive therapies for superficial BCC might be the first choice of treatment in the future. These non-invasive treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better cosmetic results than SE and are therefore also used in the Maastricht University Medical Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes grow deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment. A potential better or equal way to determine the BCC subtype might be the clinical diagnosis. To our knowledge, there is no literature about the diagnostic value of the clinical diagnosis to determine the subtype of BCC seen in the SE/MMS specimen. We want to confirm the hypothesis that the clinical diagnosis is as good as, or even better than the histological diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this case, patients don't have to undergo an extra procedure, diagnostic route is shortened.

- Primary objective: to establish the observed agreement of clinical diagnosis compared to histological diagnosis by to determine the most aggressive subtype of BCC

- Secondary objectives: inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC.


Condition Intervention
Basal Cell Carcinoma
Procedure: Punch biopsy
Procedure: Surgical excision

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Diagnosis Versus Histological Diagnosis by Punch Biopsy to Determine the Subtype of Basal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Diagnostic value of clinical diagnosis [ Time Frame: Within 24 hours after the patient presents at the outpatient department of dermatology ] [ Designated as safety issue: No ]
    The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.

  • Diagnostic value of punch biopsy [ Time Frame: Histology within 2-3 weeks after the clinical diagnosis ] [ Designated as safety issue: No ]
    The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.

  • Diagnostic value of the surgical excision (SE)/ Mohs micrographic surgery (MMS) [ Time Frame: Within 1 month after the punch biopsy ] [ Designated as safety issue: No ]
    The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.


Secondary Outcome Measures:
  • Interobserver and intraobserver variability [ Time Frame: After clinical diagnosis, punch biopsy and surgical excision have been performed ] [ Designated as safety issue: No ]
    To assess the inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC.


Biospecimen Retention:   Samples Without DNA

A punch biopsy and surgical excision of the BCC will be performed. Both biospecimens will be prepared with either frozen section histology, or paraffin embedded fixed tissue pathology.


Enrollment: 150
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Basal cell carcinoma

- Population: Eligible are patients (men and women) ≥18 years of age who visit the outpatient department of dermatology of the Maastricht University Medical Centre because of a clinically suspected BCC.

- Inclusion criteria: All patients aged 18 years or older, otherwise healthy, with ≤ three primary (no previous treatment) clinically determined BCC.

- Exclusion criteria: Patients using immunosuppressive drugs. Genetic skin cancer disorders. Earlier treatments at the same site. Age under 18 years. More than 3 clinical suspected BCCs. Not capable of informed consent.

Procedure: Punch biopsy
Punch biopsy is a 10 minutes treatment at the outpatient department of dermatology. Patient will lie down on a bed, the skin will be disinfected and local anaesthesia (lidocaine 1% with epinephrine) will be given, which is briefly painful. Then a PB of 3 mm is taken from the most suspected area. In the case of continuing bleeding the wound will be sutured. A properly taken biopsy will leave no or minimal scarring, but this is not relevant since a SE will be performed afterwards. In very rare cases post-biopsy bleeding or infection occurs.
Procedure: Surgical excision

Surgical excision takes place in 30 minutes. Patient will lie down on a bed, the skin will be disinfected and local anaesthesia will be given. sBCC and nBCC will be excised with a 3 mm margin, aBCC with a 5 mm margin. Most BCC can be surgically excised, but some have to be treated with Mohs micrographic surgery (MMS). MMS ensures total BCC removal, preserving as much surrounding skin with 100% margin control. All BCCs will be excised with a 2 mm margin and examined under the microscope. This will totally take 1.5-2.0 hours. If tumour is still present, another tissue layer with 2 mm margin will be excised. It usually takes removal of 1-3 tissue layers to complete MMS.

After both treatments, wounds will be sutured and removed after 1-2 weeks, depending on the localisation. Within the first two weeks posttreatment, patients have to avoid physical heavy movements and keep the suture dry. Possible complications: scarring, continuous or subsequent bleeding, infection and dehiscent wounds.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible are patients (men and women) ≥18 years of age who visit the outpatient department of dermatology of the Maastricht University Medical Centre because of a clinically suspected BCC. The subtype will be determined by clinical diagnosis, histopathological examination of tissue derived from a PB and SE/MMS. Recruitment of the required number of patients (150 histological proven BCC, see below) should present no problems.

Criteria

Inclusion Criteria:

  • All patients aged 18 years or older, otherwise healthy, with ≤ three primary (no previous treatment) clinically determined BCC will be recruited for this study.

Exclusion Criteria:

  • Patients using immunosuppressive drugs. Genetic skin cancer disorders. Earlier treatments at the same site. Age under 18 years. More than 3 clinical suspected BCCs. Not capable of informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370824

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
Erasmus Medical Centre Rotterdam
Rotterdam, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Nicole WJ Kelleners-Smeets, MD, PhD Maastricht University Medical Center, Maastricht, the Netherlands
Principal Investigator: Ellen RM de Haas, MD, PhD Erasmus Medical Centre, Rotterdam, the Netherlands
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01370824     History of Changes
Other Study ID Numbers: MEC 112041 (35344.068.11)
Study First Received: June 7, 2011
Last Updated: May 16, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Diagnosis
Clinical
Punch biopsy
Surgical excision
Histology
Histopathology
Observed agreement
Diagnostic value
Accuracy
Interobserver variability
Intraobserver variability

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on August 26, 2014