Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas.

The definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection.

Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination

histological examination

Barbara Costantini, MD

Complete disease removal has the greatest impact in the treatment of advanced ovarian cancer, both during primary debulking surgery (PDS) and interval debulking surgery (IDS), but, contrarily to PDS, no consensus exist on the interpretation of the absence of residual tumor at IDS. In addition, chemotherapy induces fibrotic changes that can hinder the surgeon's ability to properly assess the spread of abdominal disease. The aim of the study is to evaluate the accuracy of visual inspection compared to histopathological examination at the level of the diaphragmatic peritoneum in patients undergoing surgery after neoadjuvant chemotherapy.

All data of patients subjected to IDS between October 2016 and October 2019 with evidence of suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at intra-operative evaluation have been collected. Diaphragmatic peritoneum was classified as negative, not-surely pathologic and certainly pathologic by the surgeon, and based on the surgeon's opinion, a diaphragmatic biopsy or peritonectomy was then performed. The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas, while the definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection. Residual disease was indicated at the end of each intervention and classified as no residual disease (RD=0, complete cytoreduction), less than 1 centimeter (RD \</= 1 cm, optimal cytoreduction) or more than 1 cm (RD \> 1 cm, sub-optimal cytoreduction).

Pathological specimens' results were also divided in negative (no evidence of disease), microscopic evidence of residual disease (\</= 3 mm) or macroscopic signs of residual disease (\> 3 mm). Microscopic and macroscopic disease were both considered as positive for residual disease.

General early post-operative complications (arising within 30 days from surgery), and complications related to diaphragmatic peritonectomy, as post-operative pleural effusion, were classified using the extended Clavien-Dindo classification of surgical complications.

The primary end-point of the study was to evaluate the accuracy, sensitivity and specificity of the visual inspection compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS.

The secondary endpoints were to evaluate the rate of early postoperative complications related to diaphragmatic peritonectomy and assess whether this procedure may delay the re-start of post-operative chemotherapy.

Intra-operative Visual Examination at IDS

Can Intraoperative Visual Examination of Diaphragmatic Peritoneum be a Reliable Tool to Modulate the Extent of Interval Debulking Surgery in Advanced Ovarian Cancer? The VIPER (VIsual Peritoneal Evaluation of Residual Disease) Study

to evaluate the accuracy of the visual examination compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS

to evaluate the rate of early postoperative complications related to diaphragmatic peritonectomy

Catholic University of the Sacred Heart

Professor

Immune System Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Hypersensitivity

Mouth Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.

Visual Examination

Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.

OraTest

Mark Chambers, DMD

Primary Objectives:

1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
2. To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity.

Secondary Objectives:

1. To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors.
2. To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity.
3. To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions.
4. To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions.
5. To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).

OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells.

SCHEDULED EVALUATION (FIRST VISIT):

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your medical history will be recorded. Women who are able to have children must have a negative urine pregnancy test. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the first visit.

Visual Exam - If you are found to be eligible to take part in this study, you will have a visual examination where a doctor (Examiner #1) will look inside your mouth very carefully to look for any abnormal lesions and check the glands in your neck. This is called the visual exam.

Rinse Staining Procedure (OraTest®) - A second doctor (Examiner #2) will perform another oral exam, followed by the new test using OraTest®. This new test uses a blue dye which may stain any potential cancer blue so it may make it easier for the doctor to detect any abnormal lesions in your mouth. You will be asked not to have intensely-colored sweets like lollipops or drinks like black currant juice within 24 hours of your scheduled visit. First you will rinse your mouth with about 6 teaspoons of vinegar solution for about 20 seconds and spit it out. Next you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Then you will rinse your mouth with about 2 teaspoons of OraTest® for 20 seconds and spit it out. Then you will rinse your mouth with about 6 teaspoons of vinegar solution for 20 seconds and then spit it out. Then you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Examiner 2 will then check and see if any abnormal tissue absorbed the dye.

If no suspicious lesions are found by either doctor, you will have completed the study. You will be asked to notify the clinic, by phone, if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you.

If any suspicious lesions are found by either doctor (or both), then you will be asked to return in about 2 weeks to confirm the result. This is called the Confirmation Exam.

CONFIRMATION EXAM (SECOND VISIT):

At the visit to confirm the result, you will be examined by the same doctor(s) who found the suspicious lesion(s). The doctor(s) will use the same examination method that was used during the first visit. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the second visit.

If you have any suspicious lesions, a specialist at M. D. Anderson will biopsy your lesion(s), at this second visit or within 5 days after the visit. During the biopsy, the doctor may use the OraTest® cotton swab to help locate the suspicious spot. If the dye is used at the biopsy visit, your heart rate, breathing, temperature, and blood pressure will be measured before and after the use of OraTest®. After locating the spot, the doctor will perform the biopsy. This means that some tissue lining in your mouth from the suspicious area will be removed. Some of your tissue will be sent to a laboratory for diagnosis. Your doctor will decide the type of care you may need based on the results of the biopsy. The biopsy procedure is standard practice and may happen even if you did not participate in this study. After the biopsy is taken of the lesion, you will have completed the study.

If a suspicious lesion is found and you are required to have a biopsy, a sample of tissue from the biopsy will be sent to a laboratory outside of M.D. Anderson for review and diagnosis. Medical research including genetic testing, chromosomal analysis and other tests may be performed on your biopsy. These samples cannot be returned to you because the tissue is destroyed during the genetic tests. Before your tissue is sent to the outside laboratory your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by BRT Laboratories Inc. for additional research.

If no suspicious lesions are seen at this second visit, then you have completed the study. If the dye was used during the exam, then you will be asked to notify the clinic by phone if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you.

This is an investigational study. OraTest® has not yet been FDA approved for commercial use. All study procedures and OraTest® will be provided free of charge; the Sponsor will pay for the study drug and pregnancy test if necessary. If further standard of care is needed (for example, due to abnormalities found), you and/or your insurance company will be responsible for the cost. Insurance companies and Medicare may not pay for the costs of some research studies like this one. If your insurance company does not cover the cost of care, then you will have to pay these costs. You have the right to ask what it will cost you to take part in this study or to have other treatments. If you withdraw from the study early, you will only be paid for the portion of the study that you completed. Up to 4000 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.

OraTest in Combination With Visual Examination and Visual Examination Alone

Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)

Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.

Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.

Zila Biotechnology, Inc.

M.D. Anderson Cancer Center

Study was terminated after first patient enrolled.

Visual oral exam, followed by OraTest Rinse Staining Procedure

OraTest + Visual Exam

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination by sponsor resulted in only 1 patient enrolled and no analysis.

Mark Chambers, MS, DMD / Professor

No analysis was performed. Study was terminated by sponsor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intra-operative Visual Examination at IDS	NCT04444934	Diaphragm Disea...	histological ex...	-	Catholic University of the Sacred Heart
Intra-operative Visual Examination at IDS	NCT04444934	Diaphragm Disea...	histological ex...	-	Catholic University of the Sacred Heart
OraTest in Combination With Visual Examination and Visual Examination Alone	NCT00537199	Head And Neck C... Oropharynx Canc...	Visual Examinat... OraTest	45 Years -	M.D. Anderson Cancer Center

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