Clinical Diagnosis of Basal Cell Carcinoma Subtype

NCT01370824 | Completed

• 1 other identifier: MEC 112041 (35344.068.11)
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Basal Cell Carcinoma

Keywords

Diagnosis; Clinical; Punch biopsy; Surgical excision; Histology; Histopathology; Observed agreement; Diagnostic value; Accuracy; Interobserver variability; Intraobserver variability

Outcome Measures

Primary Outcomes (3)

• Diagnostic value of clinical diagnosis

  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.

  Within 24 hours after the patient presents at the outpatient department of dermatology

• Diagnostic value of punch biopsy

  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.

  Histology within 2-3 weeks after the clinical diagnosis

• Diagnostic value of the surgical excision (SE)/ Mohs micrographic surgery (MMS)

  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.

  Within 1 month after the punch biopsy

Secondary Outcomes (1)

• Interobserver and intraobserver variability

  After clinical diagnosis, punch biopsy and surgical excision have been performed

Study Arms (1)

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; Procedure: Surgical excision

Interventions

Punch biopsy PROCEDURE

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.

Basal cell carcinoma

Surgical excision PROCEDURE

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.

Basal cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (2)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Erasmus Medical Centre Rotterdam

Rotterdam, Netherlands

Location

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.

MeSH Terms

Conditions

Carcinoma, Basal Cell; Disease

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 10, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

NL (2)