Biopsy, Colposcopy
Conditions
Brief summary
A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer. The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector
Detailed description
The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.
Interventions
DEVICEe2 Cell Collector [SoftPAP(R)]
Cervical cells collected using the e2 Cell Collector \[SoftPAP(R)\]
DEVICESpatula/Brush
Cervical cells collected using a combination of a cervical spatula and an endocervical brush
Sponsors
University Hospitals Cleveland Medical Center
CytoCore, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ages 18 years old and above * Women scheduled to undergo colposcopy
Exclusion criteria
* Patients who have had a hysterectomy * Patients who are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cell Collection Efficacy | At the time of cell collection. | True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient. |
| Specimen Adequacy | At time of cell collection | Number and percentage of samples classified as adequate for diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human Papilloma Virus (HPV) Detection Frequency | At the time of cell collection. | Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay |
Countries
United States
Participant flow
Recruitment details
Patients presenting for a previously scheduled colposcopy subsequent to an abnormal Pap result were recruited for this study.
Participants by arm
| Arm | Count |
|---|---|
| SoftPAP Samples collected using the SoftPAP Collector | 366 |
| Brush/Spatula Samples collected using an endocervical brush and cervical spatula | 371 |
| Total | 737 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 9 | 8 |
| Overall Study | Sample not collected | 1 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | SoftPAP | Brush/Spatula | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 6 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 366 Participants | 365 Participants | 731 Participants |
| Region of Enrollment United States | 366 participants | 371 participants | 737 participants |
| Sex: Female, Male Female | 366 Participants | 371 Participants | 737 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 348 | 0 / 355 |
| serious Total, serious adverse events | 0 / 348 | 0 / 355 |
Outcome results
Primary
Cell Collection Efficacy
True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.
Time frame: At the time of cell collection.
Population: 79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SoftPAP | Cell Collection Efficacy | True Negative (TN) (Cytology Dx vs (Bx + ECC)) | 33 Participants |
| SoftPAP | Cell Collection Efficacy | False Negative (FN) (Cytology Dx vs (Bx + ECC)) | 20 Participants |
| SoftPAP | Cell Collection Efficacy | False Positive (FP) (Cytology Dx vs (Bx + ECC)) | 42 Participants |
| SoftPAP | Cell Collection Efficacy | Excluded - Bx/ECC results not reported | 79 Participants |
| SoftPAP | Cell Collection Efficacy | True Positive (TP) (Cytology Dx vs (Bx + ECC) | 174 Participants |
| Brush/Spatula | Cell Collection Efficacy | Excluded - Bx/ECC results not reported | 81 Participants |
| Brush/Spatula | Cell Collection Efficacy | True Positive (TP) (Cytology Dx vs (Bx + ECC) | 170 Participants |
| Brush/Spatula | Cell Collection Efficacy | True Negative (TN) (Cytology Dx vs (Bx + ECC)) | 14 Participants |
| Brush/Spatula | Cell Collection Efficacy | False Positive (FP) (Cytology Dx vs (Bx + ECC)) | 63 Participants |
| Brush/Spatula | Cell Collection Efficacy | False Negative (FN) (Cytology Dx vs (Bx + ECC)) | 27 Participants |
Primary
Specimen Adequacy
Number and percentage of samples classified as adequate for diagnosis
Time frame: At time of cell collection
Population: Includes all cytology specimens
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SoftPAP | Specimen Adequacy | Satisfactory for Diagnosis | 343 Participants |
| SoftPAP | Specimen Adequacy | Unsatisfactory for Diagnosis | 4 Participants |
| SoftPAP | Specimen Adequacy | Excluded - Slide Preparation Error | 1 Participants |
| Brush/Spatula | Specimen Adequacy | Excluded - Slide Preparation Error | 1 Participants |
| Brush/Spatula | Specimen Adequacy | Satisfactory for Diagnosis | 352 Participants |
| Brush/Spatula | Specimen Adequacy | Unsatisfactory for Diagnosis | 2 Participants |
Secondary
Human Papilloma Virus (HPV) Detection Frequency
Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay
Time frame: At the time of cell collection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SoftPAP | Human Papilloma Virus (HPV) Detection Frequency | HPV Positive by Hybrid Capture-II | 165 Participants |
| SoftPAP | Human Papilloma Virus (HPV) Detection Frequency | HPV Negative by Hybrid Capture-II | 82 Participants |
| SoftPAP | Human Papilloma Virus (HPV) Detection Frequency | Hybrid Capture-II Results Not Reported | 101 Participants |
| Brush/Spatula | Human Papilloma Virus (HPV) Detection Frequency | HPV Positive by Hybrid Capture-II | 214 Participants |
| Brush/Spatula | Human Papilloma Virus (HPV) Detection Frequency | HPV Negative by Hybrid Capture-II | 104 Participants |
| Brush/Spatula | Human Papilloma Virus (HPV) Detection Frequency | Hybrid Capture-II Results Not Reported | 37 Participants |