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Completed

NCT Number: NCT03593681

Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy

Prospective, multi-center, non-randomized study to assess the ability of the Cytuity device to collect cell samples from the fallopian tube that can be evaluated for the presence or absence of malignancy.

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Key information

Conditions

Fallopian Tube Cancer Abdominal Neoplasms Adnexal Diseases Adnexal Mass Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Adenocarcinoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders High Grade Serous Carcinoma Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Ovary Cancer Peritoneal Carcinoma Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Scripps Clinic Medical Group, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is medically cleared for surgery
  • Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
  • Subject must be 18 years of age
  • Subject must be able to provide informed consent

Exclusion criteria

  • Contraindication to hysteroscopy
  • Acute pelvic inflammatory disease
  • Active or recent lower pelvic infection
  • Pregnancy
  • Delivery or termination of a pregnancy in the past 6 weeks
  • Known tubal obstruction
  • Tubal ligation
  • Invasive carcinoma of the cervix or endometrium
  • Intolerance of anesthesia

Treatment and study plan

Hysteroscopic cell sampling of the fallopian tube

Device

Hysteroscopic fallopian tube biopsy

Other names: Cytuity

Primary outcomes

  1. Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement

    Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy

    Evaluate the sensitivity and specificity of the cytological samples collected from the fallopian tube in determining the presence or absence of malignancy for fallopian tube involvement as compared to the surgical histology results. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.

Secondary outcomes

  1. PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement

    Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy

    Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the ovaries and fallopian tube for fallopian tube involvement. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.

  2. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube

    Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the fallopian tube.

  3. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries

    Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the ovaries for epithelial malignancies.

  4. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis

    Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology for fallopian tube involvement at the subject level. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

The nCYT Study: A Powered Study to Evaluate the Sensitivity and Specificity of Cytological Evaluation of Fallopian Tube Samples Collected by the Cytuity in Determining the Presence of Malignancy

Acronym: nCYT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2018
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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