Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05051722
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2021-09-11
Brief Title:
Leveraging Methylated DNA Markers MDMs in the Detection of Endometrial Cancer Ovarian Cancer and Cervical Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Leveraging Methylated DNA Markers MDMs in the Detection of Endometrial Cancer Ovarian Cancer and Cervical Cancer a Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ECHO
Brief Summary:
The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic unique endometrial cervical and ovarian cancer cancer-specific methylated DNA markers and high-risk human papilloma virus HR-HPV detected in vaginal fluid andor plasma
This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer EC and endometrial hyperplasia with atypia AEH in tampon-collected vaginal fluid and 2 ovarian cancer OC in plasma and tampon-collected vaginal fluid Additionally it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer CC MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologieser detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies
This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer EC and endometrial hyperplasia with atypia AEH in tampon-collected vaginal fluid and 2 ovarian cancer OC in plasma and tampon-collected vaginal fluid Additionally it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer CC MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologieser detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies
Detailed Description:
Detection of endometrial ovarian and cervical cancers at an early stage vastly increases the chances of cure and may also avert morbidity secondary to surgical staging radiation andor chemotherapy Despite the great successes of cervical cancer screening comparable early detection methods for other gynecologic cancers and their precursors are not available While nearly 15 million women per year in the United States are evaluated for abnormal uterine bleeding AUB or postmenopausal bleeding PMB the most common symptom of endometrial cancer most undergo an invasive diagnostic biopsy with the finding of benign etiology
Vaginal bleeding is often the only presenting symptom of women ultimately diagnosed with endometrial cancer EC or its precursor lesion endometrial hyperplasiaEH More than 90 of women with EC present with vaginal bleeding Cervical cancer and cervical dysplasia can present as intermenstrual bleeding post-coital bleeding or other abnormal vaginal bleeding However most women who present with AUB or PMB have a benign etiology
There are approximately 70 million women 45 years of age in the United States based on the most recent census data Between 4-11 of women will be worked up for perimenopausal AUB or PMB in their lifetime As only 5-10 of those women will have an EC or EH there is a great clinical need for a less invasive clinical diagnostic test that can reliably distinguish between benign uterine bleeding and bleeding associated with an underlying endometrial cancer cervical cancer or a precursor lesion
Vaginal bleeding is often the only presenting symptom of women ultimately diagnosed with endometrial cancer EC or its precursor lesion endometrial hyperplasiaEH More than 90 of women with EC present with vaginal bleeding Cervical cancer and cervical dysplasia can present as intermenstrual bleeding post-coital bleeding or other abnormal vaginal bleeding However most women who present with AUB or PMB have a benign etiology
There are approximately 70 million women 45 years of age in the United States based on the most recent census data Between 4-11 of women will be worked up for perimenopausal AUB or PMB in their lifetime As only 5-10 of those women will have an EC or EH there is a great clinical need for a less invasive clinical diagnostic test that can reliably distinguish between benign uterine bleeding and bleeding associated with an underlying endometrial cancer cervical cancer or a precursor lesion
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-10826 | REGISTRY | NCI | None |