Seminoma and dysgerminoma Cancer
Conditions
Interventions
OTIS-S will include patients with stage I seminoma or dysgerminoma and will use a seamless, phased approach to evaluation. In part A (single-arm), 260 patients will undergo regular miRNA testing along
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
All
Age
0 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed testicular pure seminoma* or extra-cranial dysgerminoma 2. Primary cancer managed by orchiectomy or complete surgical removal of dysgerminoma (trial entry is permitted within 8 weeks following surgery, up to a maximum of 10 weeks under exceptional circumstances.) 3. Stage I based on CT or MRI abdomen and pelvis and CT chest. For participants under the age of 19, pelvic ultrasound (US) may be used at physician’s discretion where MRI is not possible or where US is used routinely at site. 4. Normal post-operative tumour markers as follows (may have been raised pre-operatively and immediately post-operatively, but have returned to normal range): a.AFP 10 and < = 25 ng/ml and confirmed as not rising on three successive tests may be accepted as eligible after discussion with Chief Investigator or delegate] b.ß-HCG< = 4 IU/L c.LDH< 1.2 x upper limit of normal 5. No adjuvant therapy planned 6. Participant (or, where the participant is under 16 years old, their parent or guardian) has given written informed consent prior to any study-specific procedures. *Patients with any non-seminomatous elements, including teratoma, are not eligible
Exclusion criteria
Exclusion criteria: 1. Previous contralateral testis tumour within 3 years of trial entry. 2. Previous or concurrent illness or condition which, in the investigator’s opinion, would interfere with participation in the trial 3. Pregnancy (pregnancy can be excluded on the basis of ß-HCG result) 4. Unable/unwilling to comply with trial visit schedule/trial assessments.
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactDeborah Gardiner
Outcome results
None listed