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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Fabien Le Floc'h, Project Manager
- 電話番号：+330630447709
- メール：fabien.lefloch@monitoring-force.fr
研究場所
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Gironde
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Bordeaux、Gironde、フランス、33000
- 募集
- Clinique Tivoli Ducos
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コンタクト：
- Horace ROMAN, Physician
- 電話番号：+330677651269
- メール：horace.roman@gmail.com
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Ille-et-Vilaine
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Saint-Grégoire、Ille-et-Vilaine、フランス、35760
- まだ募集していません
- Hôpital privé Saint-Grégoire
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コンタクト：
- Sophie LORAND, Physician
- 電話番号：+330299239368
- メール：slorand@vivalto-sante.com
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Morbihan
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Lorient、Morbihan、フランス、56100
- まだ募集していません
- Groupe Hospitalier Bretagne Sud - GHBS - Lorient
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コンタクト：
- Antoine SCATTARELLI, Physician
- 電話番号：+330297067437
- メール：a.scattarelli@ghbs.bzh
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Moselle
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Peltre、Moselle、フランス、57245
- まだ募集していません
- Hôpital de Mercy - CHR Metz Thionville
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コンタクト：
- Laurianne BOUSCHBACHER, Physician
- 電話番号：+330387186426
- メール：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、フランス、42270
- まだ募集していません
- CHU de Saint Etienne
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コンタクト：
- Céline CHAULEUR, Physician
- 電話番号：+330477828383
- メール：celine.chauleur@chu-st-etienne.fr
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Pyrénées Atlantiques
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Pau、Pyrénées Atlantiques、フランス、64000
- まだ募集していません
- Centre Hospitalier de Pau
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コンタクト：
- Aurélie CHIROL, Physician
- 電話番号：+330559726998
- メール：aurelie.chirol@ch-pau.fr
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Seine-maritime
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Montivilliers、Seine-maritime、フランス、76290
- まだ募集していません
- Hôpital Jacques Monod - GH du Havre
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コンタクト：
- Adnene TRIMECH, Physician
- 電話番号：+330621581730
- メール：agnene.trimech@ch-havre.fr
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Endometriosis cohort performing Ziwig ENDOTEST®
|
EHP 5+6, RAND-36 et 6 and 12 months follow-up visits
|
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 |
|---|---|---|
|
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
時間枠：Day 1, 6 months and 12 months.
|
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.
時間枠：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.
時間枠：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
|
|
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Describe the impact of Endotest on adaptation strategies.
時間枠：6 months
|
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
|
6 months
|
|
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
時間枠：Through study completion, an average of 1 year
|
Number of patients starting an assisted reproductive technology (ART) treatment programme
|
Through study completion, an average of 1 year
|
|
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
時間枠：Through study completion, an average of 1 year
|
Number of patients for whom the ART treatment plan is amended (e.g.
switching from intrauterine insemination to IVF, surgery)
|
Through study completion, an average of 1 year
|
|
Describe the impact of Endotest's results immediately following the announcement.
時間枠：1 month
|
Personalised questionnaire on immediate emotional reactions
|
1 month
|
|
Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
時間枠：Through study completion, an average of 1 year
|
Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.).
|
Through study completion, an average of 1 year
|
|
Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
時間枠：Through study completion, an average of 1 year
|
Initiation or modification of treatments (hormonal, pain relievers, etc.).
|
Through study completion, an average of 1 year
|
|
To assess the impact of Endotest on anxiety levels.
時間枠：1 month
|
Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is
|
1 month
|
|
Compare the care provided to patients with a positive Endotest result across participating countries.
時間枠：Through study completion, an average of 1 year
|
Type of coverage and waiting period
|
Through study completion, an average of 1 year
|
|
Compare pelvic sensitivity based on Endotest results
時間枠：Day 1 and 12 months
|
Convergences Score for Pelvic-Perineal Pain Score goes from 0 to 10 Lower the score is, better the outcome is.
|
Day 1 and 12 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2025ZW03
- 2026-A00166-45 (その他の識別子：ANSM)
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
米国FDA規制機器製品の研究
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