Ovarian CancerNCT02178462
Biomarkers for Gynecologic Cancer
An observational study of Ovarian Cancer and Endometrial Cancer, run by Ajinomoto Co., Inc. at 1 site in United States.
Trial summary
A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed by multivariate statistical analyses. 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
- Ovarian Cancer, Endometrial Cancer, Benign Gynecological Disease
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2018
- 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: Participants in this study will be patients with Primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following eligibility criteria:
Who may be able to join
- Participants in this study will be patients with Primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following criteria:
- Age > 20 years (no data is currently available on use of AminoIndexTM in patients under 20 years of age or over 80 years of age)
- Willing to follow fasting and clinic visit requirements
- Ability to understand and consent to participate in study.
- Women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Women will be excluded from study participation for the following reasons:
- An inability to fast (no food or drink other than water) for 8 hours prior to the pre-surgery sample collection.
- Are known to be positive for HIV/HCV/HBV
- Pregnancy or breastfeeding (Pregnant and breastfeeding women are excluded from this study because amino acid levels are known to differ in pregnancy).
- Currently receiving investigational agents.
- History of any drug therapy or surgery for treatment of gynecological cancer
Show all 10Show fewer
- Unable to come for the blood sample collection between 6:00 AM and 12:00 Noon
- Currently undergoing dialysis
- Congenital metabolic disease
- The investigator considers individual to be ineligible based on prior medical history, histology or other findings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed by multivariate statistical analyses. However, further studies to assess whether this biomarker demonstrates the same performance characteristics in non-Japanese populations for cancer is yet to be determined.
Read the detailed description
"AminoIndex Technology" was developed based on high-throughput and absolute quantitative analysis method of amino acids and amines using UFLC-MS, and creating a clinical database to search for amino acid patterns across different diseases including cancer. "AminoIndex Technology" can evaluate certain health conditions and the possibility of diseases by analyzing the balance of plasma amino acids. Multicenter studies in Japan were conducted to develop an blood based biomarker panel for cancer.
This study wil be conducted to evaluate the performance of AminoIndexTM (gynecological) biomarker based on "AminoIndex Technology" for gynecological cancers in US populations. This will be done by analyzing plasma metabolites including amino acids, from endometrial and ovarian cancer patients, from patients with benign gynecological disease, and healthy subjects using Liquid Chromatography and Mass Spectrometry (LC-MS) and Liquid Chromatography - Tandem Mass Spectrometry (LC-MSMS).
- Medical subject headings
- Ovarian Neoplasms, Endometrial 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 |
|---|---|---|
| Primary ovarian cancer patients | Intervention will not be administered. | |
| Primary endometrial cancer patients | Intervention will not be administered. | |
| Benign gynecological disease patients | Intervention will not be administered. | |
| Healthy controls | Intervention will not be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects
Performance characteristics of the AminoIndexTM biomarker will be evaluated by analyzing blood and comparing results between cancer patients, benign gynecological diseases, and healthy subjects. (AUC of the ROC curve, sensitivity, specificity, and other measures of performance)
Measured: Baseline
Secondary outcomes (1)
To identify and quantify new blood amino metabolic biomarkers that are associated with gynecologic cancer
Blood will be examined for new blood amino metabolic biomarkers and their concentrations will be compared between cancer patients and benign disease patients and healthy subjects
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajinomoto Co., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
- Investigators
- David O'Malley, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178462
- Sponsor's protocol ID
- AI-2014-1
- Status last verified
- Jan 2018
- First submitted
- 23 Jun 2014
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
- ClinicalTrials.gov ID
- NCT02178462
- Acronym / sponsor ID
- AI-2014-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Ajinomoto Co., Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Study start
- Jun 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 30 Jun 2014 (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.
A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed by multivariate statistical analyses. However, further studies to assess whether this biomarker demonstrates the same performance characteristics in non-Japanese populations for cancer is yet to be determined.
Detailed description
"AminoIndex Technology" was developed based on high-throughput and absolute quantitative analysis method of amino acids and amines using UFLC-MS, and creating a clinical database to search for amino acid patterns across different diseases including cancer. "AminoIndex Technology" can evaluate certain health conditions and the possibility of diseases by analyzing the balance of plasma amino acids. Multicenter studies in Japan were conducted to develop an blood based biomarker panel for cancer.
This study wil be conducted to evaluate the performance of AminoIndexTM (gynecological) biomarker based on "AminoIndex Technology" for gynecological cancers in US populations. This will be done by analyzing plasma metabolites including amino acids, from endometrial and ovarian cancer patients, from patients with benign gynecological disease, and healthy subjects using Liquid Chromatography and Mass Spectrometry (LC-MS) and Liquid Chromatography - Tandem Mass Spectrometry (LC-MSMS).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary ovarian cancer patients | – | –Intervention will not be administered. |
| Primary endometrial cancer patients | – | –Intervention will not be administered. |
| Benign gynecological disease patients | – | –Intervention will not be administered. |
| Healthy controls | – | –Intervention will not be administered. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be patients with Primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following eligibility criteria:
Key inclusion criteria (5 listed)
- Participants in this study will be patients with Primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following criteria:
- Age > 20 years (no data is currently available on use of AminoIndexTM in patients under 20 years of age or over 80 years of age)
- Willing to follow fasting and clinic visit requirements
- Ability to understand and consent to participate in study.
- Women of all races and ethnic groups are eligible for this trial.
Key exclusion criteria (10 listed)
- An inability to fast (no food or drink other than water) for 8 hours prior to the pre-surgery sample collection.
- Are known to be positive for HIV/HCV/HBV
- Pregnancy or breastfeeding (Pregnant and breastfeeding women are excluded from this study because amino acid levels are known to differ in pregnancy).
- Currently receiving investigational agents.
- History of any drug therapy or surgery for treatment of gynecological cancer
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
Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects
Time frame: Baseline
Performance characteristics of the AminoIndexTM biomarker will be evaluated by analyzing blood and comparing results between cancer patients, benign gynecological diseases, and healthy subjects. (AUC of the ROC curve, sensitivity, specificity, and other measures of performance)
1 secondary outcome
To identify and quantify new blood amino metabolic biomarkers that are associated with gynecologic cancer
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
David O'Malley, MD principal investigator
Ohio State 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 Ovarian Cancer and Endometrial Cancer, run by Ajinomoto Co., Inc. at 1 site in United States.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Jan 2018. 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 United States. 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?
Results are not available in the source record.
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?
Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects (time frame: Baseline). 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 31 Jan 2018.