Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329323
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-12-04
Brief Title:
SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUMMER
Brief Summary:
The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression imaging and radiomic profiles of malignant ovarian germ cell tumours MOGCT compared to patients with a benign OGCT and no ovarian pathology
The main questions it aims to answer are
1 To understand the circulating miRNA expression of malignant ovarian germ cell tumours MOGCTs compared to those with benign ovarian germ cell tumours BOGCTs
2 To understand the imaging profile of MOGCTs compared to that of BOGCTs
3 To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
4 To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
5 To see if we can link the micro RNAs in tumour samples to those found in blood samples and to find a plausible explanation for why these micro RNAs are raised in terms of the tumour biology itselfaims
Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment andor remission andor relapse If they have surgery a pathology sample will be taken from the main tumour specimen Radiomic analysis will take place on existing ultrasound images of their mass
Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie If a patient with a BOGCT requires surgery a pathology sample will be taken from the main tumour specimen Radiomic analysis will take place on existing ultrasound images of their benign mass
The main questions it aims to answer are
1 To understand the circulating miRNA expression of malignant ovarian germ cell tumours MOGCTs compared to those with benign ovarian germ cell tumours BOGCTs
2 To understand the imaging profile of MOGCTs compared to that of BOGCTs
3 To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
4 To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
5 To see if we can link the micro RNAs in tumour samples to those found in blood samples and to find a plausible explanation for why these micro RNAs are raised in terms of the tumour biology itselfaims
Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment andor remission andor relapse If they have surgery a pathology sample will be taken from the main tumour specimen Radiomic analysis will take place on existing ultrasound images of their mass
Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie If a patient with a BOGCT requires surgery a pathology sample will be taken from the main tumour specimen Radiomic analysis will take place on existing ultrasound images of their benign mass
Detailed Description:
Case population MOGCTs
1 Serum aFP alpha fetoprotein hCG human chorionic gonadotrophin LDH lactate dehydrogenase and Ca125 cancer antigen 125 tumour markers measured at time of diagnosis
2 Additional serum and plasma sample to be obtained at the same time as initial bloods
3 Subsequent serum and plasma samples to be obtained as per study arms 1-3 based on cancer staging
4 Tissue samples will be obtained at the time of surgery
Control population
Participants acting as controls will be identified from those attending for TV-USS where either a benign teratoma or no pathology is identified eg from a gynaecology clinic A total of 26ml of blood will be taken Serum aFP hCG LDH and Ca125 will be measured as per routine clinical practice in patients with a benign OGCT
Patients in the control population benign germ cell tumours or patients with no known gynaecological pathology will have a single blood test for miRNA analysis
If participants require an operation for the benign GCT tissue samples will be obtained at the time of surgery
miRNA analysis will be performed using NanoString for the discovery panel Further targeted sequencing will be performed in the larger prospective study using specific miRNA panels This may be done using NanoString or a custom MiRNA assay primer
Endpoint The pilot will be completed after the final patient has completed 12 months of follow up The pilot data analysis will take place at that point
We anticipate that the study will end 12 months after the final participant has completed 24 months of follow up which gives 12 months for analysis of the samples The number of participants to take part will be based on a power calculation performed at the time of analysis of the pilot data
DATA COLLECTION AND MANAGEMENT Patients will enter study arm 1-3 based on cancer staging or will belong to the control group
Each participant will be followed up for a maximum of 2 years after they receive their definitive treatment surgery andor neoadjuvant chemotherapy We anticipate this will be a maximum of 30 months total time in the study
An interim analysis of data will be performed at 12 months with a view to
1 Identify key miRNAs for prospective validation
2 Allow for appropriate power calculation of the prospective validation study
1 Serum aFP alpha fetoprotein hCG human chorionic gonadotrophin LDH lactate dehydrogenase and Ca125 cancer antigen 125 tumour markers measured at time of diagnosis
2 Additional serum and plasma sample to be obtained at the same time as initial bloods
3 Subsequent serum and plasma samples to be obtained as per study arms 1-3 based on cancer staging
4 Tissue samples will be obtained at the time of surgery
Control population
Participants acting as controls will be identified from those attending for TV-USS where either a benign teratoma or no pathology is identified eg from a gynaecology clinic A total of 26ml of blood will be taken Serum aFP hCG LDH and Ca125 will be measured as per routine clinical practice in patients with a benign OGCT
Patients in the control population benign germ cell tumours or patients with no known gynaecological pathology will have a single blood test for miRNA analysis
If participants require an operation for the benign GCT tissue samples will be obtained at the time of surgery
miRNA analysis will be performed using NanoString for the discovery panel Further targeted sequencing will be performed in the larger prospective study using specific miRNA panels This may be done using NanoString or a custom MiRNA assay primer
Endpoint The pilot will be completed after the final patient has completed 12 months of follow up The pilot data analysis will take place at that point
We anticipate that the study will end 12 months after the final participant has completed 24 months of follow up which gives 12 months for analysis of the samples The number of participants to take part will be based on a power calculation performed at the time of analysis of the pilot data
DATA COLLECTION AND MANAGEMENT Patients will enter study arm 1-3 based on cancer staging or will belong to the control group
Each participant will be followed up for a maximum of 2 years after they receive their definitive treatment surgery andor neoadjuvant chemotherapy We anticipate this will be a maximum of 30 months total time in the study
An interim analysis of data will be performed at 12 months with a view to
1 Identify key miRNAs for prospective validation
2 Allow for appropriate power calculation of the prospective validation study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None