Uterine Cervical NeoplasmsNCT01874548
MR Metabolic Biomarkers for Cervical Cancer
An observational study of Uterine Cervical Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to understand the function of human papillomavirus (HPV) infection and autophagy (a cellular catabolic degradation response to stress) in the… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms
- How many people
- 136 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jun 2016
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in a tertiary referral center.
Who may be able to join
- be able to give informed consent.
- female patients between 20 and 80 years of age.
- biopsy proven newly diagnosed cervical cancer clinical stage International Federation of Gynecology and Obstetrics (FIGO) Ib and above.
- patients must be willing to undergo standard treatment such as surgery or chemo-radiation therapy.
Who cannot join
- patients who are judged to be noncompliant to treatment or not accessible for follow up.
- patients with contraindications to magnetic resonance imaging (MRI) scanning, such as claustrophobia, cardiac pacemaker, metal implants in field of view, or unable to cooperate for MRI study due to mental status.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Radiology, Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
About this study
Official title: Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.
The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to understand the function of human papillomavirus (HPV) infection and autophagy (a cellular catabolic degradation response to stress) in the metabolic alterations in cervical cancer.
Read the detailed description
In the first part of this project, we aim to identify the differences in cancer metabolism between normal and cervical cancer. Conventional MR study plus magnetic resonance spectroscopy (MRS) and diffusion weighted imaging (DWI) sequences will be carried out on 30 eligible surgical candidates for pretreatment clinical assessment. Metabolites in cancer tissue will be collected during operation and analyzed using high resolution MRS, and compared with control group comprising 30 patients with normal cervical tissue. The primary endpoint of this part is to identify different MRS profiles between normal and cancer subjects. We will investigate the underlying biological mechanism between these two groups by evaluating status of HPV infection and autophagy. In the second part, we aim to understand cancer metabolism in cervical cancers infected by different types of HPV. We plan to enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis. The primary endpoint of this part is to compare MRS profiles from cancer tissue infected with different HPV genotypes, particularly HPV type 16 and HPV type 18. The secondary endpoint is to correlate the tissue MRS profiles with the in vivo MRS/DWI measured by clinical MR scanner. In the third part of this project, we aim to investigate cancer metabolism under combined chemoradiation therapy (CCRT). We plan to enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high-resolution MRS. Tissue MRS profiles will be correlated with the HPV, E6/E7 and autophagy.
The advance in knowledge of this project is to unwire the complex relationship among cancer metabolism, HPV infection and autophagy in cervical cancer. The clinical impact is the development of MR biomarkers for cancer metabolism and autophagy, both play important roles in the resistance to cancer therapy. The inherited non-invasiveness and non-radiation nature makes MR technique an ideal platform for clinical usage.
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Autophagy, Cancer metabolism, Cervical cancer, Diffusion weighted imaging, Human papillomavirus, Magnetic resonance spectroscopy.
- Medical subject headings
- Uterine Cervical Neoplasms
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 |
|---|---|---|
| Normal cervix | Control group (n=30) comprising surgical candidates with normal cervical tissue will be collected for comparison. | |
| Cervical cancer | 1. 1st year: 30 surgical candidates with cervical cancer tissue collected during operation. 2. 2nd year: Enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis. 3. 3rd year: enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high resolution MRS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amounts of metabolites in uterine cervical tissue
Measured: up to 8 weeks of magnetic resonance imaging and spectroscopy exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gigin Lin, Chang Gung Memorial Hospital
- Investigators
- Gigin Lin, MD, PhD, Principal investigator, Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874548
- Sponsor's protocol ID
- 102-0620A3
- Status last verified
- Aug 2016
- First submitted
- 6 Jun 2013
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lin G, Lai CH, Tsai SY, Lin YC, Huang YT, Wu RC, Yang LY, Lu HY, Chao A, Wang CC, Ng KK, Ng SH, Chou HH, Yen TC, Hung JH. 1 H MR spectroscopy in cervical carcinoma using external phase array body coil at 3.0 Tesla: Prediction of poor prognostic human papillomavirus genotypes. J Magn Reson Imaging. 2017 Mar;45(3):899-907. doi: 10.1002/jmri.25386. Epub 2016 Jul 19.
PubMed 27434095
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.
- ClinicalTrials.gov ID
- NCT01874548
- Acronym / sponsor ID
- 102-0620A3
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Autophagy, Cancer metabolism, Cervical cancer, Diffusion weighted imaging, Human papillomavirus, Magnetic resonance spectroscopy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Jun 2013 (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 purposes of this study are: (1) to develop magnetic resonance (MR) imaging and spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to understand the function of human papillomavirus (HPV) infection and autophagy (a cellular catabolic degradation response to stress) in the metabolic alterations in cervical cancer.
Detailed description
In the first part of this project, we aim to identify the differences in cancer metabolism between normal and cervical cancer. Conventional MR study plus magnetic resonance spectroscopy (MRS) and diffusion weighted imaging (DWI) sequences will be carried out on 30 eligible surgical candidates for pretreatment clinical assessment. Metabolites in cancer tissue will be collected during operation and analyzed using high resolution MRS, and compared with control group comprising 30 patients with normal cervical tissue. The primary endpoint of this part is to identify different MRS profiles between normal and cancer subjects. We will investigate the underlying biological mechanism between these two groups by evaluating status of HPV infection and autophagy. In the second part, we aim to understand cancer metabolism in cervical cancers infected by different types of HPV. We plan to enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis. The primary endpoint of this part is to compare MRS profiles from cancer tissue infected with different HPV genotypes, particularly HPV type 16 and HPV type 18. The secondary endpoint is to correlate the tissue MRS profiles with the in vivo MRS/DWI measured by clinical MR scanner. In the third part of this project, we aim to investigate cancer metabolism under combined chemoradiation therapy (CCRT). We plan to enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high-resolution MRS. Tissue MRS profiles will be correlated with the HPV, E6/E7 and autophagy.
The advance in knowledge of this project is to unwire the complex relationship among cancer metabolism, HPV infection and autophagy in cervical cancer. The clinical impact is the development of MR biomarkers for cancer metabolism and autophagy, both play important roles in the resistance to cancer therapy. The inherited non-invasiveness and non-radiation nature makes MR technique an ideal platform for clinical usage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal cervix | – | –Control group (n=30) comprising surgical candidates with normal cervical tissue will be collected for comparison. |
| Cervical cancer | – | –1. 1st year: 30 surgical candidates with cervical cancer tissue collected during operation. 2. 2nd year: Enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis. 3. 3rd year: enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high resolution MRS. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a tertiary referral center.
Key inclusion criteria (4 listed)
- be able to give informed consent.
- female patients between 20 and 80 years of age.
- biopsy proven newly diagnosed cervical cancer clinical stage International Federation of Gynecology and Obstetrics (FIGO) Ib and above.
- patients must be willing to undergo standard treatment such as surgery or chemo-radiation therapy.
Key exclusion criteria (2 listed)
- patients who are judged to be noncompliant to treatment or not accessible for follow up.
- patients with contraindications to magnetic resonance imaging (MRI) scanning, such as claustrophobia, cardiac pacemaker, metal implants in field of view, or unable to cooperate for MRI study due to mental status.
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
the amounts of metabolites in uterine cervical tissue
Time frame: up to 8 weeks of magnetic resonance imaging and spectroscopy exam
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 15 Aug 2016.
- Background: PubMed 27434095Lin G, Lai CH, Tsai SY, Lin YC, Huang YT, Wu RC, Yang LY, Lu HY, Chao A, Wang CC, Ng KK, Ng SH, Chou HH, Yen TC, Hung JH. 1 H MR spectroscopy in cervical carcinoma using external phase array body coil at 3.0 Tesla: Prediction of poor prognostic human papillomavirus genotypes. J Magn Reson Imaging. 2017 Mar;45(3):899-907. doi: 10.1002/jmri.25386. Epub 2016 Jul 19.
- 1 H MR spectroscopy in cervical carcinoma using external phase array body coil at 3.0 Tesla: Prediction of poor prognostic human papillomavirus genotypes.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gigin Lin, MD, PhD principal investigator
Department of Medical Imaging and Intervention, Chang Gung Memorial 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 Uterine Cervical Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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 15 Aug 2016. 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 Taiwan. 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?
the amounts of metabolites in uterine cervical tissue (time frame: up to 8 weeks of magnetic resonance imaging and spectroscopy exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874548, which also lists 1 linked publication.
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 15 Aug 2016.