Papanicolaou SmearNCT00520117
Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
An observational study of Papanicolaou Smear, run by Mahidol University at 1 site in Thailand.
Trial summary
The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papanicolaou Smear
- How many people
- 151 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients having pap-smear at Ratchawithi Hospital
Who may be able to join
- female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.
Who cannot join
- has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
- has other concurrent/active STD's
- has a history of known prior vaccination with an HPV vaccine
- has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.
Read the detailed description
This study will be a Thailand, clinic-based, cross-sectional, questionnaire study. Approximately 151 female participants will be enrolled. Study staff will interview the subject to collect basis demographic data and self reported medical history. And the subjects will be given the questionnaire packet for self-administration. After subjects complete the packet, study staff will review the questionnaires for completeness prior to the study subject leaving the clinic.
- Conditions
- Papanicolaou Smear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| negative pap-smear | Not described | |
| positive pap-smear | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological burden of women with abnormal pap-smear
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papanicolaou SmearStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punnee Pitisuttithum, Mahidol University
- Investigators
- Punnee Pitisuttithum, Professor, Principal investigator, Department of Clinical ITropical Medicine, Faculty of Tropical Medicine, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520117
- Sponsor's protocol ID
- 2007-024
- Status last verified
- Sep 2019
- First submitted
- 22 Aug 2007
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
- ClinicalTrials.gov ID
- NCT00520117
- Acronym / sponsor ID
- 2007-024
- Conditions
- Papanicolaou Smear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.
Detailed description
This study will be a Thailand, clinic-based, cross-sectional, questionnaire study. Approximately 151 female participants will be enrolled. Study staff will interview the subject to collect basis demographic data and self reported medical history. And the subjects will be given the questionnaire packet for self-administration. After subjects complete the packet, study staff will review the questionnaires for completeness prior to the study subject leaving the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| negative pap-smear | – | – |
| positive pap-smear | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients having pap-smear at Ratchawithi Hospital
Key inclusion criteria (1 listed)
- female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.
Key exclusion criteria (4 listed)
- has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
- has other concurrent/active STD's
- has a history of known prior vaccination with an HPV vaccine
- has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
psychological burden of women with abnormal pap-smear
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punnee Pitisuttithum, Professor principal investigator
Department of Clinical ITropical Medicine, Faculty of Tropical Medicine, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papanicolaou Smear, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological burden of women with abnormal pap-smear (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.