Ovarian CancerSMARAGDNCT05129969
Registry Platform Ovarian and Endometrial Cancer
An observational study of Ovarian Cancer and Endometrial Cancer, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Ovary Neoplasm
- What is being tested?
- Physician's choice according to patient's needs.
- Type of treatment
- Injection or infusion
- How many people
- 1,975 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2021to Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.
Who may be able to join
- Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
- patients with FIGO stage IIb-IV OC who are starting systemic treatment or
- patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease.
- Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
- Signed and dated informed consent (IC):
- Patients participating in PRO module: IC before first therapy cycle
- Patients not participating in PRO module: IC no later than six weeks after start of first therapy cycle
Who cannot join
- newly diagnosed early-stage OC (FIGO stage I-IIa)
- Low grade mOC OR
- Early-stage EC (FIGO stage I-II)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Multiple sites all over Germany
Multiple Locations
iOMEDICO AG, +49 761 152420, info@iomedico.com
About this study
Official title: SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.
Read the detailed description
SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.
The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
Health-related quality of life (HRQoL) will be evaluated for up to three years.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Ovary Neoplasm, Endometrial Neoplasms, Carcinoma, Ovarian, Carcinoma
- Being tested
- Physician's choice according to patient's needs.
- Keywords
- Registry, Health service research, Epidemiology, Germany, Palliative treatment, Palliative care
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician's choice according to patient's needs.Other
Routine care as per site standard.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer | Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
* with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or
* with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease. Receives: Other: Physician's choice according to patient's needs. | |
| Endometrial cancer | Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy. Receives: Other: Physician's choice according to patient's needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of treatment (treatment reality).
Documentation of anamnestic data and therapy sequences.
Measured: 3 years per patient
Secondary outcomes (5)
Best Response.
Documentation of response rates per line of treatment.
Measured: 3 years per patient
Progression-free survival.
Documentation of progression-free survival per line of treatment.
Measured: 3 years per patient
Overall survival.
Documentation of overall survival per line of treatment.
Measured: 3 years per patient
Health-related quality of life (Patient-reported outcome, PRO).
Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale
Measured: 3 years per patient
Health-related quality of life (Patient-reported outcome, PRO).
Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale
Measured: 3 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start25 Nov 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (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.
- More trials run by iOMEDICO AGThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,975 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Decker, Prof.Dr., Study chair, RavensburgIngolf Juhasz-Böss, Prof.Dr., Study chair, FreiburgElmar Stickeler, Prof.Dr., Study chair, AachenDirk Watermann, Prof.Dr., Study chair, FreiburgAnja Welt, Dr., Study chair, EssenAchim Wöckel, Prof.Dr., Study chair, Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129969
- Sponsor's protocol ID
- IOM-110401
- Acronym
- SMARAGD
- Status last verified
- Jan 2026
- First submitted
- 10 Nov 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
- ClinicalTrials.gov ID
- NCT05129969
- Acronym / sponsor ID
- SMARAGD / IOM-110401
- Conditions
- Ovarian Cancer, Endometrial Cancer, Ovary Neoplasm, Endometrial Neoplasms, Carcinoma, Ovarian, Carcinoma
- Keywords
- Registry, Health service research, Epidemiology, Germany, Palliative treatment, Palliative care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,975 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 Nov 2021 (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 purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.
Detailed description
SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.
The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
Health-related quality of life (HRQoL) will be evaluated for up to three years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer | – | Other: Physician's choice according to patient's needs.Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer): * with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or * with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease. |
| Endometrial cancer | – | Other: Physician's choice according to patient's needs.Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.
Key inclusion criteria (7 listed)
- Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
- Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
- Signed and dated informed consent (IC):
Key exclusion criteria (3 listed)
- newly diagnosed early-stage OC (FIGO stage I-IIa)
- Low grade mOC OR
- Early-stage EC (FIGO stage I-II)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician's choice according to patient's needs.Routine care as per site standard. | Other | Endometrial cancer, Ovarian cancer |
Primary outcome
Course of treatment (treatment reality).
Time frame: 3 years per patient
Documentation of anamnestic data and therapy sequences.
5 secondary outcomes
Best Response.
Time frame: 3 years per patient
Progression-free survival.
Time frame: 3 years per patient
Overall survival.
Time frame: 3 years per patient
Health-related quality of life (Patient-reported outcome, PRO).
Time frame: 3 years per patient
Health-related quality of life (Patient-reported outcome, PRO).
Time frame: 3 years per patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- 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.
Thomas Decker, Prof.Dr. study chair
Ravensburg
Ingolf Juhasz-Böss, Prof.Dr. study chair
Freiburg
Elmar Stickeler, Prof.Dr. study chair
Aachen
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 iOMEDICO AG at 1 site in Germany.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact iOMEDICO AG (+49 761 15242-0, info@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of treatment (treatment reality). (time frame: 3 years per patient). 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 28 Jan 2026.