Mucinous ovarian cancer, mucinous appendiceal and pseudomyxoma peritonei cancer. Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women over the age of 18 years with capacity to give informed consent and from the following patient groups: Sub-Study 1 - Diagnostic: 1.1. Participants undergoing surgery for adnexal masses. 1.2. Participants with confirmed biopsy of mucinous ovarian cancer prior to start of treatment. Sub-Study 2 – Follow-up: 2.1. Participants with a confirmed histological biopsy diagnosis of primary mucinous ovarian cancer after completion of first-line treatment. Sub-Study 3 – Appendiceal/ pseudomyxoma peritonei Cancer 3.1. Participants with a pre-operative clinical radiological diagnosis of pseudomyxoma peritonei. 3.2. Participants with a confirmed histological diagnosis of low grade appendiceal mucinous neoplasm (LAMN) and appendiceal carcinomas (excluding non-mucin-producing and neuroendocrine tumours).
Exclusion criteria
Exclusion criteria: Sub-Study 1: 1.1. Participants lacking capacity to consent. 1.2. Using hormonal contraception / implant within last 3 months. 1.3. Used Hormone Replacement Therapy or GnRH analogues in last 3 months. 1.4. Used steroid treatment in last 3 months including inhalers. 1.5. Commenced chemotherapy treatment for ovarian carcinoma. 1.6. Undergoing delayed debulking surgery for ovarian cancer after chemotherapy. Sub-Study 2: 2.1. Participants lacking capacity to consent. 2.2. Using hormonal contraception / implant in last 3 months. 2.3. Used HRT or GnRH analogues in last 3 months. 2.4. Used steroid treatment in last 3 months including inhalers. Sub-Study 3: 3.1. Participants lacking capacity to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression of steroidogenic genes, enzymes and metabolites from the ovaries. This will be measured from the output of 24 hour urine samples collected from patients. For study 1 - The urinary steroid metabolome will be profiled via GC-MS and other technologies to determine the “steroid fingerprint” in MOC, MBT, and benign ovarian tumours. For study 2 - The urinary steroid metabolome in confirmed MOC will be profiled via GC-MS and other technologies to determine if steroid profiles change during follow-up or at recurrence. For study 3 - The urinary steroid metabolome will be profiled via GC-MS and other technologies to determine the “steroid fingerprint” in MOC, MBT, benign ovarian tumours, and mucinous appendiceal or pseudomyxoma peritoneal cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom, Wales