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子宮内膜がん、卵巣がん、および子宮頸がんの検出におけるメチル化 DNA マーカー (MDM) の活用 (ECHO)

2026年11月4日 更新者：Mayo Clinic

子宮内膜がん、卵巣がん、および子宮頸がんの検出におけるメチル化 DNA マーカー (MDM) の活用: 第 II 相臨床試験

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 and/or plasma.

This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and 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 pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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, and/or 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 1.5 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 hyperplasia(EH). 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.

研究の種類

観察的

入学 (推定)

3110

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85054
        • 募集
        • Mayo Clinic
        • 主任研究者：
          • Kristina A. Butler, M.D.
        • コンタクト：
    • Florida
      • Jacksonville、Florida、アメリカ、32224
        • 募集
        • Mayo Clinic
        • コンタクト：
        • 主任研究者：
          • Tri A. Dinh, M.D.
      • Miami、Florida、アメリカ、33173
        • 募集
        • Genoma Research, Inc.
        • コンタクト：
        • 主任研究者：
          • Guillermo Lievano, D.O.
        • 副調査官：
          • Itsel Cardenas, PhD, APRN
      • Miami、Florida、アメリカ、33156
        • 積極的、募集していない
        • My GYN Care
      • Orlando、Florida、アメリカ、32806
      • Pembroke Pines、Florida、アメリカ、33029
        • 積極的、募集していない
        • Signature Women's Healthcare, LLC
      • Sarasota、Florida、アメリカ、34239
        • 募集
        • Sarasota Memorial Health Care System
        • 主任研究者：
          • Toni P Kilts, D.O.
        • コンタクト：
    • Georgia
      • Atlanta、Georgia、アメリカ、30318
        • 募集
        • Piedmont Healthcare
        • コンタクト：
        • 主任研究者：
          • Leda Portia A. Gattoc, M.D.
    • Illinois
      • Chicago、Illinois、アメリカ、60637
      • Evergreen Park、Illinois、アメリカ、60805
        • 積極的、募集していない
        • Providea Health Partners, LLC
    • Louisiana
      • New Orleans、Louisiana、アメリカ、70121
        • 募集
        • Ochsner Clinic Foundation
        • 主任研究者：
          • Diogo Torres, M.D.
        • コンタクト：
    • Michigan
      • Detroit、Michigan、アメリカ、48202
        • 募集
        • Henry Ford Health
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Ilinca Lupea, M.D.
      • Saginaw、Michigan、アメリカ、48602
        • 募集
        • Valley OB-GYN Clinic
        • コンタクト：
        • 主任研究者：
          • Olivia A. Phifer-Combs, M.D.
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • 募集
        • Mayo Clinic
        • コンタクト：
        • 主任研究者：
          • Jamie N. Bakkum-Gamez, MD
    • Mississippi
      • Jackson、Mississippi、アメリカ、39213
        • 募集
        • University of Mississippi Medical Center
        • 主任研究者：
          • Rodney Rocconi, M.D.
        • コンタクト：
        • コンタクト：
    • New York
      • Howard Beach、New York、アメリカ、11414
        • 募集
        • The Woman's Health Pavilion
        • コンタクト：
        • 主任研究者：
          • Andre H. Saad, M.D.
      • Westbury、New York、アメリカ、11590
        • 募集
        • The Woman's Health Pavilion
        • コンタクト：
        • 主任研究者：
          • Andre H. Saad, M.D.
    • North Dakota
      • Grand Forks、North Dakota、アメリカ、58206
        • 募集
        • Altru Health System
        • 主任研究者：
          • Collette Lessard, M.D.
        • コンタクト：
    • Ohio
      • Cleveland、Ohio、アメリカ、44195
        • 募集
        • Cleveland Clinic Foundation
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Michelle L. Kuznicki, M.D.
    • Texas
      • Houston、Texas、アメリカ、77018
        • 募集
        • Total Women's Care of the Heights
        • 主任研究者：
          • Vonne Jones, M.D.
        • コンタクト：
      • Katy、Texas、アメリカ、77450
        • 募集
        • Medical Colleagues of Texas, LLP
        • コンタクト：
        • 主任研究者：
          • Kelly A. McCullagh, M.D.
    • Virginia
      • Richmond、Virginia、アメリカ、23219
        • 募集
        • Virginia Commonwealth University/ Massey Cancer Center
        • 主任研究者：
          • Chelsea Salyer, M.D.
        • コンタクト：
        • コンタクト：
          • Morgan DeHart, CRC
          • 電話番号：804-827-1266
          • メール：dehart2@vcu.edu
    • Wisconsin
      • Eau Claire、Wisconsin、アメリカ、54703
        • 募集
        • Mayo Clinic Health System - Northwest Wisconsin
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Blenda Yun, M.D.
      • La Crosse、Wisconsin、アメリカ、54601
        • 募集
        • Mayo Clinic Health System - Southwest Wisconsin
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Rebecca A. Scarseth, D.O.
      • Milwaukee、Wisconsin、アメリカ、53226
        • 積極的、募集していない
        • Medical College of Wisconsin

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

Patients presenting to a GYN or GYN Surgery Clinic for evaluation of symptoms or for consultation and planned procedures as outlined in the seven study cohort descriptions.

説明

Inclusion Criteria for Cohort 1:

Patients will be ≥45 years of age and meet one of the following criteria:

  • Abnormal uterine bleeding
  • Postmenopausal bleeding

OR

Patients ages 18 - 44 years of age and meet these criteria

  • Abnormal uterine bleeding
  • One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)

Exclusion Criteria for Cohort 1:

  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Any prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia
  • Current biopsy-proven endometrial cancer or endometrial hyperplasia
  • Current biopsy-proven benign endometrial polyp
  • Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium

Inclusion Criteria for Cohort 2:

Patients will be ≥18 years of age and meet at least one of the following criteria:

  • Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D&C, hysteroscopic resection
  • Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D&C, hysteroscopic resection, etc)

Exclusion Criteria for Cohort 2:

  • Undergoing surgical procedure for recurrent or metastatic EC
  • Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis
  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Prior or current biopsy-proven cervical cancer
  • Presence of concomitant biopsy-proven cervical dysplasia
  • Any prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Prior intervention or surgery with intent to completely remove the target pathology

Inclusion Criteria for Cohort 3:

Patients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:

  • History of current abnormal cervical/endocervical Pap test for which the patient is presenting for colposcopy
  • Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated
  • Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)

Exclusion Criteria for Cohort 3:

  • History of pelvic or vaginal radiotherapy
  • Prior total hysterectomy (cervix removed) for any indication
  • Current known pregnancy diagnosis
  • Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass
  • Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode

Inclusion Criteria for Cohort 4:

Patients will be ≥45 years of age and should meet at least one of the following criteria:

  • Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.
  • Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.

Exclusion Criteria for Cohort 4:

  • Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis
  • Any surgery within the past 3 months
  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Prior or current biopsy-proven gynecologic cancer
  • Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
  • Prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis
  • Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode

Inclusion Criteria for Cohort 5:

Patients with a uterus will be ≥45 years of age and should meet the following criteria:

  • Presenting for GYN wellness exam, ± Pap test
  • No change in medical conditions, new diagnoses, or new medications within the past 6 months

Exclusion Criteria for Cohort 5:

  • Pap test or cervical biopsy within the past 1 month
  • Endometrial biopsy or office hysteroscopy within the past 1 month
  • Any surgery within the past 3 months
  • Prior hysterectomy
  • Current known pregnancy diagnosis
  • Prior or current biopsy-proven gynecologic cancer
  • Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
  • Prior pelvic or vaginal radiotherapy
  • Any prior cancer (except basal cell skin cancer) within the past 5 years
  • Chemotherapy within the past 5 years
  • Criteria met for inclusion in any of the other study cohorts

Inclusion Criteria for Cohort 6:

Patients ≥50 years of age and:

  • Postmenopausal
  • At least 1 intact ovary
  • Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)
  • Planned surgery for the adnexal mass
  • For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)

Exclusion criteria for Cohort 6:

  • Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)
  • Chemotherapy for cancer treatment within the past 5 years prior to collection
  • Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection
  • Surgical candidates for recurrent ovarian cancer
  • History of pelvic or vaginal radiation therapy
  • Known current synchronous endometrial cancer or hyperplasia
  • Known current cervical, vaginal, or vulvar dysplasia

Inclusion criteria for Cohort 7:

Women will be ≥18 years of age and meet the following criteria:

  • Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology
  • Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy
  • At least one intact ovary
  • For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)

Exclusion criteria for Cohort 7:

  • Patients with recurrent OC
  • Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
  • Chemotherapy for cancer treatment within the past 5 years prior to collection
  • History of pelvic or vaginal radiation therapy
  • Known current synchronous endometrial cancer or hyperplasia
  • Known current cervical, vaginal, or vulvar dysplasia
  • Current known pregnancy diagnosis

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
Cohort 1 - AUB / PMB

Patients ≥45 years of age, presenting with abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB). Patients ages 18 - 44 years of age, presenting with abnormal uterine bleeding (AUB) and a risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use). These presenting symptoms clinically warrant evaluation such as an endometrial biopsy to assess for underlying endometrial cancer, endometrial hyperplasia or other endometrial pathology.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 2 - Biopsy-proven EC or AEH or EIN

Patients ≥18 years of age with biopsy-proven endometrial cancer (EC), atypical endometrial hyperplasia (AEH), or endometrial intraepithelial neoplasia (EIN) presenting for surgical management of their endometrial pathology.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 3 - Cervix pathology

Patients ≥18 years of age presenting for a clinically indicated colposcopy, cervical biopsy, or surgical excision, as follow-up for an abnormal Pap test or cervical mass identified on physical exam. Final clinical diagnoses within this cohort may include mild cervical intraepithelial neoplasia (CIN 1), moderate and/or severe CIN (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancers (adenocarcinoma or squamous cell carcinoma), or possibly benign findings.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 4 - Benign Uterine Pathology

Patients with any of four benign gynecologic conditions including: uterine fibroids, benign endometrial polyps, adenomyosis and endometriosis. All patients enrolled in this cohort will be undergoing clinically indicated gynecologic surgery (hysterectomy, myomectomy, polypectomy, or laparoscopic tissue excision) for the specific benign gynecologic condition. Verification of the final benign diagnosis will be based on pathology diagnosis of clinically-indicated tissue removed during surgery.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 5 - Healthy Control Women

Healthy patients with a uterus, ≥45 years of age presenting for GYN wellness exam to serve as a control group. These patients will have no clinically evident gynecologic precancers, gynecologic cancers, or clinically evident or symptomatic benign gynecologic conditions. These patients will not have known or clinically suspected AUB, PMB, fibroids, endometriosis, benign endometrial polyps, or adenomyosis, nor will they have any active gynecologic or non-gynecologic acute medical conditions.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 6- Isolated Adnexal Mass Cohort (ovarian or fallopian mass)

Patients ≥50 years of age and postmenopausal (12 months since LMP or available blood hormone levels confirming postmenopausal status) and an isolated adnexal mass or isolated bilateral adnexal masses being surgically removed. These patients may have a final diagnosis of any of the following: benign ovarian neoplasm, borderline tumor of the ovary, or clinically early-stage OC.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Cohort 7 - OC Cohort - Biopsy proven or clinically suspected ovarian cancer (OC)

Patients ≥18 years of age with ovarian cancer (OC) (clinically probable based on distribution of pelvic/abdominal masses on imaging, elevated CA-125, ascites, and/or imaging-guided biopsy proven) presenting for neoadjuvant chemotherapy or primary surgical management (debulking or staging) of their OC. The umbrella of OC also includes fallopian tube cancer and primary peritoneal cancer. All histologies are eligible for enrollment.
診断テスト：Vaginal Fluid Collection

A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.

他の名前：
  • 膣液
診断テスト：Blood Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.
時間枠：18 months

Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based endometrial cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of endometrial cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
18 months
Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.
時間枠：18 months

Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based ovarian cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of ovarian cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
18 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Using 95% specificity cutoffs of the final MDM EC panel, determine the false positive rate among women undergoing surgical removal of common benign gynecologic pathology
時間枠：18 months

As part of this biomarker test development, understanding whether common non-cancerous uterine or gynecologic conditions may also lead to the finding of currently apparent endometrial cancer-specific MDMs in vaginal fluid is critical in determining specificity, positive predictive value, and negative predictive value of the test.
18 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Mayo Clinic

捜査官

  • 主任研究者：Jamie N. Bakkum-Gamez, M.D.、Mayo Clinic

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年8月3日

一次修了 (推定)

2027年7月30日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2021年9月11日

QC基準を満たした最初の提出物

2021年9月11日

最初の投稿 (実際)

2021年9月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 20-012833

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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