Placental site and other rare trophoblastic tumours database

• Research type

  Research Database

• IRAS ID

  295670

• Contact name

  Matthew Winter

• Contact email

  matthewwinter@nhs.net

• Research summary

  An International Collaborative Project to Extend an Established Database for Placental Site and Other Rare Trophoblastic Tumours

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  21/EM/0104

• Date of REC Opinion

  26 May 2021

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  The following information will be recorded on a secure, password-protected database:
  Treating centre and physician
  Unique patient ID
  Diagnosis: PSTT or ETT or Ultra-High Risk Gestational Trophoblastic Neoplasia (UHR GTN) and the criteria met for diagnosis of UHR GTN (hCG greater than one million IU/L, interval from antecedent pregnancy to diagnosis of 2.8 years or more, WHO score of 12 or more, FIGO stage 4, early chemotherapy resistance, any other local clinician considers UHR)

  Demographics: Patient year of birth; date of presentation; age at presentation
  - Patient date of delivery of antecedent pregnancy; delivery to presentation time
  interval and details of antecedent pregnancy, Blood group, Ethnicity

  Complete Obstetric history and details of antecedent pregnancy
  Initial treatment and details of any prior molar pregnancy

  Diagnosis and Pathology: approximate date of onset of symptoms, date of diagnosis, time between symptoms and diagnosis, presenting symptoms, diagnostic method of GTN, histology, sites of metastatic disease, WHO score and FIGO stage, details and results of any imaging, serum hCG and any other tumour markers, hCG assay used

  Treatment: types and details of first treatments - surgery / chemotherapy / other. Surgery details to include type of surgery, chemotherapy details to include regimen details, response and how assessed, toxicities. These details will be collected for each line of treatment received, including whether patients received any high dose chemotherapy or immunotherapy / other novel therapies

  Follow-up: details of treatment outcome, status (alive with or without disease, death, lost to Follow-up). Date when last seen, last hCG recorded. Follow up status events: late effects, subsequent pregnancy events and outcomes. If death cause and date of death.

• Research programme

  n/a

• Research database title

  An International Collaborative Project to Extend an Established Database for Placental Site and Other Rare Trophoblastic Tumours

• Establishment organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Establishment organisation address

  Of Trust Headquarters

  8 Beech Hill Road

  Sheffield

  S10 2SB