None listed
Conditions
Brief summary
The CODEC study (Circulating tumOur Dna in Endometrial Cancer) is pilot project exploring whether circulating tumour DNA (cancer genetic material collected from a simple blood test) can be used to predict endometrial cancer recurrence and potentially guide treatment. Who is it for? You may be eligible for this study if you have had a new diagnosis of a Type 2 endometrial cancer (which includes serous, clear cell, carcinosarcoma and high-grade (grade 3) endometrioid histologies) and are planned for surgery and have not had prior chemotherapy or radiation. Study details All patients enrolled in the study will have a comprehensive genomic tumour assessment and serial blood collections beginning pre-surgery and continuing for up to two years following surgery. Participants will also have MRI and PET scans. It is hoped that this research will help determine if genetic material collected using a simple blood test can help predict recurrence of endometrial cancer.
Interventions
All patients enrolled in the study will have comprehensive genomic tumour assessment and serial blood collections to facilitate analysis of circulating tumour DNA plus CA 125 and HE4 beginning pre-operatively and continuing for up to two years following surgery.
Pre-screening takes place when the patient is first diagnosed with endometrial cancer (pre-surgery, post biopsy procedure) and also involves a pre-operative MRI and PET scan. A repeat PET scan will also occur 12 months from the date o
All patients enrolled in the study will have comprehensive genomic tumour assessment and serial blood collections to facilitate analysis of circulating tumour DNA plus CA 125 and HE4 beginning pre-operatively and continuing for up to two years following surgery. Pre-screening takes place when the patient is first diagnosed with endometrial cancer (pre-surgery, post biopsy procedure) and also involves a pre-operative MRI and PET scan. A repeat PET scan will also occur 12 months from the date of surgery. If clinical relapse is suspected, a repeat blood collection and PET will be performed. This is an observational study with no impact on treatment which is given at the clinician’s discretion.
Sponsors
Epworth HealthCare
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Patients with Type 2* endometrial cancer on pipelle/curettage /endometrial biopsy procedure -Planned for gynaecological surgery -Consenting to the collection of bio-specimens, including blood and tissue *Type 2 endometrial cancer includes the following histologies: serous, clear cell, carcinosarcoma, high-grade (grade 3) endometrioid. Mixed tumours included if the Type 2 component (grade 3) is greater than or equal to 10% of the tumour. -44% (20/45) of recruited patients must have at least one of the following high risk features on pre-op imaging: i. Lymphadenopathy based on pre-op CT or MRI (Lymph node greater than or equal to 10 mm) ii. Deeply invasive primary with invasion into the cervical stroma on MRI iii. PET positive disease outside the primary based on pre-op PET -Of the remaining patients (approximately 25), at least 36% (9) must have myometrial invasion greater than or equal to 50% on pre-op MRI
Exclusion criteria
-Women with other active malignancy or a history of malignancy (excluding a completely resected superficial skin cancer or a cancer that was treated more than 2 years ago and remains in remission). -Any participant that remains on anti-cancer treatment following a cancer diagnosis -Women that have no residual high grade (grade 3) tumour at the time of resection (unless adequate DNA is available from the endometrial biopsy sample) -Inability to consent due to cognitive impairment
Outcome results
None listed