Impact of Endotest on Patients' Quality of Life: a Cohort Study (ENDOLIFE)
Ziwig Endotest® ('Endotest') is marketed in several countries, including Switzerland, which was the first country to make it available in 2022. Since February 2025, several French clinical investigation sites have been offering Endotest, developed by Ziwig, under the innovation funding. Initially, this innovation funding enabled 2,500 patients to be included in a clinical trial (ENDOBEST: ID-RCB 2024-A02092-45). Since the end of December 2025, it has been expanded and now covers a further 22,500 patients whose are not included in the trial. This medical device is based on Next-Generation Sequencing combined with analytical algorithms and enables the identification of endometriosis from a saliva sample. This non-invasive test aims to improve patient care by reducing diagnostic delays and guiding treatment strategies.
Despite the available data on its diagnostic performance, the impact of Endotest on patients' quality of life, their emotional experience, their coping strategies, and their care pathways remains insufficiently documented. Indeed, the Endotest result (positive or negative) can significantly influence these various aspects. This cohort study aims to assess the impact of Endotest on patients' quality of life, primarily using validated self-report questionnaires and clinical data from medical records. By including a large sample of patients, this study aims to provide robust and generalisable data that will be useful for clinicians and patients themselves.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Fabien Le Floc'h, Project Manager
- 전화번호: +330630447709
- 이메일: fabien.lefloch@monitoring-force.fr
연구 장소
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Gironde
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Bordeaux, Gironde, 프랑스, 33000
- 모병
- Clinique Tivoli Ducos
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연락하다:
- Horace ROMAN, Physician
- 전화번호: +330677651269
- 이메일: horace.roman@gmail.com
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Ille-et-Vilaine
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Saint-Grégoire, Ille-et-Vilaine, 프랑스, 35760
- 아직 모집하지 않음
- Hôpital privé Saint-Grégoire
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연락하다:
- Sophie LORAND, Physician
- 전화번호: +330299239368
- 이메일: slorand@vivalto-sante.com
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Morbihan
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Lorient, Morbihan, 프랑스, 56100
- 아직 모집하지 않음
- Groupe Hospitalier Bretagne Sud - GHBS - Lorient
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연락하다:
- Antoine SCATTARELLI, Physician
- 전화번호: +330297067437
- 이메일: a.scattarelli@ghbs.bzh
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Moselle
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Peltre, Moselle, 프랑스, 57245
- 아직 모집하지 않음
- Hôpital de Mercy - CHR Metz Thionville
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연락하다:
- Laurianne BOUSCHBACHER, Physician
- 전화번호: +330387186426
- 이메일: laurianne.bouschbacher@chr-metz-thionville.fr
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Pays de la Loire Region
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Saint-Priest-en-Jarez, Pays de la Loire Region, 프랑스, 42270
- 아직 모집하지 않음
- Chu de Saint Etienne
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연락하다:
- Céline CHAULEUR, Physician
- 전화번호: +330477828383
- 이메일: celine.chauleur@chu-st-etienne.fr
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Pyrénées Atlantiques
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Pau, Pyrénées Atlantiques, 프랑스, 64000
- 아직 모집하지 않음
- Centre Hospitalier de Pau
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연락하다:
- Aurélie CHIROL, Physician
- 전화번호: +330559726998
- 이메일: aurelie.chirol@ch-pau.fr
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Seine-maritime
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Montivilliers, Seine-maritime, 프랑스, 76290
- 아직 모집하지 않음
- Hôpital Jacques Monod - GH du Havre
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연락하다:
- Adnene TRIMECH, Physician
- 전화번호: +330621581730
- 이메일: agnene.trimech@ch-havre.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Women with a prescription for Endotest
- Women aged 18 to 43
- Who have dated and signed the consent form
- Affiliated with the French healthcare system or covered by health insurance abroad
Exclusion Criteria:
Contraindications for the use of Endotest:
- Current pregnancy;
- Medical history of cancer or HIV infection;
- Active infection at the time of saliva collection;
- Significant difficulty reading and understanding the language of the country in which the participant is located.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Endometriosis cohort performing Ziwig ENDOTEST®
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EHP 5+6, RAND-36 et 6 and 12 months follow-up visits
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
기간: Day 1, 6 months and 12 months.
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Endometriosis-specific quality of life score on the EHP-5 + 6 questionnaire (Endometriosis Health Profile - 11 items). Score goes from 0 to 44. Higher the score is, worse the outcome is. |
Day 1, 6 months and 12 months.
|
|
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
기간: Day 1, 6 months and 12 months
|
Score for each of the 8 dimensions of quality of life on the RAND-36 questionnaire (declined version of the 36-Item Short Form Survey (SF-36)) Score goes from 0 to 100 for each ones of the 8 dimensions.
Higher the score is, better the outocome is.
|
Day 1, 6 months and 12 months
|
|
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
기간: 6 months
|
Factors associated with the level of endometriosis-specific quality of life (EHP-5+6 (Endometriosis Health Profile - 11 items)) at 6 months. Score goes from 0 to 44. Higher the score is, worse the outcome is. |
6 months
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To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
기간: 6 months
|
Factors associated with the level of each of the 8 dimensions of general quality of life (RAND-36 (declined version of the 36-Item Short Form Survey (SF-36)) at 6 months. Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is. |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Describe the impact of Endotest on adaptation strategies.
기간: 6 months
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Brief-COPE score (Brief Coping Orientation to Problems Experienced) Score goes from 1 to 4 for the 3 subscales (Problem Focussed, Emotion Focussed, Avoidant) There is no direct correlation between higher/lower scores and better/worse outcomes
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6 months
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Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
기간: Through study completion, an average of 1 year
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Number of patients starting an assisted reproductive technology (ART) treatment programme
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Through study completion, an average of 1 year
|
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Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
기간: Through study completion, an average of 1 year
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Number of patients for whom the ART treatment plan is amended (e.g.
switching from intrauterine insemination to IVF, surgery)
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Through study completion, an average of 1 year
|
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Describe the impact of Endotest's results immediately following the announcement.
기간: 1 month
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Personalised questionnaire on immediate emotional reactions
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1 month
|
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Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
기간: Through study completion, an average of 1 year
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Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.).
|
Through study completion, an average of 1 year
|
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Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
기간: Through study completion, an average of 1 year
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Initiation or modification of treatments (hormonal, pain relievers, etc.).
|
Through study completion, an average of 1 year
|
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To assess the impact of Endotest on anxiety levels.
기간: 1 month
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Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is
|
1 month
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Compare the care provided to patients with a positive Endotest result across participating countries.
기간: Through study completion, an average of 1 year
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Type of coverage and waiting period
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Through study completion, an average of 1 year
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Compare pelvic sensitivity based on Endotest results
기간: Day 1 and 12 months
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Convergences Score for Pelvic-Perineal Pain Score goes from 0 to 10 Lower the score is, better the outcome is.
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Day 1 and 12 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025ZW03
- 2026-A00166-45 (기타 식별자: ANSM)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Questionnaire에 대한 임상 시험
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University Hospital, Toulouse완전한
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Assistance Publique - Hôpitaux de Paris완전한
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T.C. ORDU ÜNİVERSİTESİMacquarie University, Australia모집하지 않고 적극적으로
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Centre Hospitalier Emile RouxUniversité Clermont-Auvergne, France아직 모집하지 않음
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Cambridge University Hospitals NHS Foundation TrustUniversity of Cambridge알려지지 않은근골격계 질환 | 근골격계 부상
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University Hospital, Rouen아직 모집하지 않음
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Medical University of Lublin완전한
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Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한