Please select the eligibility criteria that correspond to the clinical trial below.
Title: Melanomas Excised in Primary Care vs Secondary Care Excision
Brief Summary: Melanoma is the most dangerous skin cancer and is becoming commoner, largely due to increased foreign holidays and use of sun-beds. Melanoma usually begins as a new or changing mole. If it is picked-up quickly enough it can be removed in a simple operation and effectively cured. GPs can do this operation and many are highly experienced and skilled in minor skin surgery. However, guidelines written by hospital specialists insist that all patients who might have a melanoma should not be treated by GPs, but should be referred to hospital. This contrasts with Australia, where melanoma is commoner and initial treatment by GPs is standard practice. This creates several potential problems. First, melanoma can be difficult to diagnose. Many moles that do not look concerning based on checklists do turn out to be melanoma, and the opposite frequently occurs too, moles that look worrying at initial examination are not melanoma. Second, people are becoming more skin aware and GPs are checking moles much more often. Sensibly many of these patients are being sent to hospital for a check, although most will not have melanoma. Third, as a result hospital skin clinics and minor surgery lists are becoming very busy and waiting times are ever increasing. Fourth, the many people who have a melanoma that is not clinically obvious are waiting an increasingly long time to have it diagnosed and treated in hospital, and this could actually mean that melanoma has more chance to spread while they wait. The investigators conducted studies on 1200 people diagnosed with a melanoma in Northeast Scotland between 1991 and 2008 and found that 20% of these people had had their melanoma diagnosed and first treated by their GP. These patients were no more likely to receive improper treatment than those that had been referred to hospital. Also people who had had their melanoma cut out by a GP were no more likely to die from melanoma, and they actually required less hospital visits afterward. This suggests that the guidelines could be changed to allow GPs to treat suspicious moles. The investigators think this will be better for patients and the NHS in the long-run. However, the investigators cannot recommend changes to the guidelines on the basis of local research. For this reason, the investigators wish to extend the study using data from 18,000 patients diagnosed with melanoma from across Scotland. The results of this inclusive study will inform how the health service should deal with the growing problem of suspicious moles in the future.


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:

* The lesion is pigmented (i.e., melanin, keratin, blood)
* Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
* The diameter of the pigmented area is between 2 and 22 millimeters
* The lesion is accessible to the MelaFind hand-held imaging device
* The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form

Exclusion Criteria:

* The patient has a known allergy to isopropyl alcohol
* The lesion has been previously biopsied, excised, or traumatized
* The skin is not intact (e.g., open sores, ulcers, bleeding)
* The lesion is within 1 cm of the eye
* The lesion is on mucosal surfaces (e.g., lips, genitals)
* The lesion is on palmar hands
* The lesion is on plantar feet
* The lesion is on or under nails
* The lesion is located on or in an area of visible scarring
* The lesion contains foreign matter (e.g., tattoo, splinter, marker)
D: Inclusion Criteria:

* A diagnosis of malignant melanona

Exclusion Criteria:

* None

Answer: D