RegistriesNCT03864640
Reliability and Validity of Mediterranean Colorectal Cancer Registry
An observational study of Registries, run by Volkan Doğru at 1 site in Turkey (Türkiye).
Trial summary
The study will examine the validity and reliability of the Mediterranean Colorectal Cancer Registry. Aspects of the analysis will cover parallel forms reliability, test-retest reliability, split half internal consistency and face validity of the Mediterranean Colorectal Cancer Registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Registries
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2019to 1 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adult patients with colorectal cancer
Who may be able to join
- Adult patients with colorectal cancer.
Who cannot join
- Patients reluctant to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study will examine the validity and reliability of the Mediterranean Colorectal Cancer Registry. Aspects of the analysis will cover parallel forms reliability, test-retest reliability, split half internal consistency and face validity of the Mediterranean Colorectal Cancer Registry.
Read the detailed description
Although central cancer registry programs have many benefits (the determination of national cancer incidences, strategic planning of health care systems etc.) data entry in such programs is often collected in restricted variables and physicians participating in the registration process may not be able to interact with each other during the management of their patients. For these reasons, a complete record in national general cancer registries can only be established retrospectively and the direct contribution to patient-specific diagnosis / treatment is limited. On the other hand, local registries have many advantages like easy integration of the data into the hospital electronic systems and multidisciplinary proactive enrollment.
Thus, characteristics of ongoing colorectal cancer registries (Swedish, South Australian, Oregon, Lublin, Ontario etc.) reported previously in the English medical literature are reviewed and an electronic form is tabulated for the Mediterranean Colorectal Cancer Registry. This study will examine the validity and reliability of this registry. Aspects of the analysis will cover construct validity, content validity, parallel forms reliability, test-retest reliability, split half internal consistency and face validity.
- Conditions
- Registries
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 |
|---|---|---|
| Colorectal cancer | Patients with colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Construct validity will be based on the combination of qualitative and statistical methods in order to develop representative and structured set of multiple-choice items for colorectal cancer registry.
Measured: 2 week
Content validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Content validity will be based on the combination of qualitative and statistical methods in order to develop shortest-possible but well-matched set of multiple-choice items reflecting the subjects being assessed in the colorectal cancer registry. .
Measured: 2 week
Secondary outcomes (5)
Parallel forms reliability of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Parallel forms reliability will be based on assessments analyzing the extent to which the items answered by different responders correlate with each other within their domain. It will be evaluated by correlation scores or positive predictive values according to the subject being assessed.
Measured: 2 week
Test-retest reliability of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Test-retest reliability will be based on the reproducibility of the answers to multiple-choice items during a specific time period of stable condition. It will be evaluated by intraclass correlation coefficient or positive predictive values according to the subject being assessed.
Measured: 2 week
Split half internal consistency of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Split half internal consistency will be based on the comparison of two sets of items inquirying the same subject. It will be evaluated by correlation scores or positive predictive values according to the subject being assessed.
Measured: 2 week
Face validity of Mediterranean Colorectal Cancer Registry: binary scoring of items
Face validity will be based on the scores of respondents indicating their overall positive or negative impression after evaluating each item for every file they registered.
Measured: 2 week
Face validity of Mediterranean Colorectal Cancer Registry: the major reason behind the negative response
For negative responses, respondents will provide further feedback whether the item was ambiguous, confusing, excessively short, excessively long or there was another reason for their negative impression.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start27 Feb 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegistriesStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volkan Doğru
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Volkan Doğru, Akdeniz University
- Investigators
- Muhittin Yaprak, Study director, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864640
- Sponsor's protocol ID
- 19920022019
- Status last verified
- Jan 2020
- First submitted
- 27 Feb 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Mediterranean Colorectal Cancer Registry
- ClinicalTrials.gov ID
- NCT03864640
- Acronym / sponsor ID
- 19920022019
- Conditions
- Registries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Volkan DoğruUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- 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 study will examine the validity and reliability of the Mediterranean Colorectal Cancer Registry. Aspects of the analysis will cover parallel forms reliability, test-retest reliability, split half internal consistency and face validity of the Mediterranean Colorectal Cancer Registry.
Detailed description
Although central cancer registry programs have many benefits (the determination of national cancer incidences, strategic planning of health care systems etc.) data entry in such programs is often collected in restricted variables and physicians participating in the registration process may not be able to interact with each other during the management of their patients. For these reasons, a complete record in national general cancer registries can only be established retrospectively and the direct contribution to patient-specific diagnosis / treatment is limited. On the other hand, local registries have many advantages like easy integration of the data into the hospital electronic systems and multidisciplinary proactive enrollment.
Thus, characteristics of ongoing colorectal cancer registries (Swedish, South Australian, Oregon, Lublin, Ontario etc.) reported previously in the English medical literature are reviewed and an electronic form is tabulated for the Mediterranean Colorectal Cancer Registry. This study will examine the validity and reliability of this registry. Aspects of the analysis will cover construct validity, content validity, parallel forms reliability, test-retest reliability, split half internal consistency and face validity.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | – | –Patients with colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patients with colorectal cancer
Key inclusion criteria (1 listed)
- Adult patients with colorectal cancer.
Key exclusion criteria (1 listed)
- Patients reluctant to participate in the study.
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
Construct validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Time frame: 2 week
Construct validity will be based on the combination of qualitative and statistical methods in order to develop representative and structured set of multiple-choice items for colorectal cancer registry.
Content validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Time frame: 2 week
Content validity will be based on the combination of qualitative and statistical methods in order to develop shortest-possible but well-matched set of multiple-choice items reflecting the subjects being assessed in the colorectal cancer registry. .
5 secondary outcomes
Parallel forms reliability of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Time frame: 2 week
Test-retest reliability of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Time frame: 2 week
Split half internal consistency of Mediterranean Colorectal Cancer Registry: answering multiple-choice items
Time frame: 2 week
Face validity of Mediterranean Colorectal Cancer Registry: binary scoring of items
Time frame: 2 week
Face validity of Mediterranean Colorectal Cancer Registry: the major reason behind the negative response
Time frame: 2 week
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 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Registries
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
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.
Muhittin Yaprak study director
Akdeniz University Hospital
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 Registries, run by Volkan Doğru at 1 site in Turkey (Türkiye).
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 1 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 18 Jan 2020. 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 Turkey (Türkiye). 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?
Construct validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items (time frame: 2 week). The study lists 2 primary outcomes in all. 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 18 Jan 2020.