Please select the eligibility criteria that correspond to the clinical trial below.
Title: In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
Brief Summary: Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.


Options:
A: Inclusion Criteria:

* Men and women ≥ 18 years of age.
* For patients with metastatic basal cell carcinoma (BCC), histological confirmation of distant BCC metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is Response Evaluation Criteria in Solid Tumors (RECIST) measurable using computed tomography (CT) or magnetic resonance imaging (MRI).
* For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable.
* For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
* For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (GDC-0449).
* For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib.

Exclusion Criteria:

* Prior treatment with vismodegib or other Hedgehog pathway inhibitors.
* Pregnancy or lactation.
* Life expectancy of \< 12 weeks.
* Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement.
* Concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
* Recent, current, or planned participation in an experimental drug study.
* History of other malignancies within 3 years of the first day of treatment with vismodegib in this study (Day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
* Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
B: DISEASE CHARACTERISTICS:

* Histologically confirmed primary basal cell skin carcinoma

  * Nodular or superficial lesion(s)\*
  * Located in low-risk areas NOTE: \*Any number of lesions are allowed but only 1 lesion per patient is selected for the study
* No genetic or nevoid conditions (e.g., Gorlin's syndrome)
* No morphoeic (microinfiltrative) histology

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* No bleeding disorder

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 1 month after study participation
* No allergy to any of the study interventions
* No life-threatening disease
* Must be available for study follow-up for up to 3 years
* Must have access to a telephone

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No concurrent participation in any other experimental trial
C: Inclusion Criteria:

* Patients must be able to adhere to all requirements of the study
* Patients must be willing to give written informed consent
* Clinically diagnosed/ clinical suspicion of basal cell carcinoma

Exclusion Criteria:

* Participating in other investigational research currently or in the previous 28 days before the study
* Patient is having a medical condition which excludes participating the research, according to the investigator
* Incapacitated subjects will not be included
* Lesion(s) on parts of the body which do not allow to adequately image the tumour with RCM.
D: Inclusion Criteria:

* Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist
* Patients seen at the outpatient clinic before 12h00 AM will be eligible to participate
* Patient is willing and able to give written informed consent
* BCC lesion is suitable for conventional surgical excision under local anesthetics
* BCC lesion is present since at least 1 month

Exclusion Criteria:

* BCC lesion in a high-risk location of the face (H-zone and ears)
* Contra-indication for conventional surgical excision (primary surgical closure seems not achievable)
* Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons)
* Patients with basal cell nevus syndrome
* Patients treated with hedgehog inhibitor medication
* Patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia
* Unavailability within the following 6 weeks (for example due to holiday or sports)
* Patients not competent to understand the procedures involved

Answer: C