Metastatic Non-small Cell Lung Cancer (NSCLC)CRISPNCT02622581
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
An observational study of Metastatic Non-small Cell Lung Cancer (NSCLC) and Non-small Cell Lung Cancer Metastatic, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer (NSCLC), Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage II
- What is being tested?
- data collection
- Type of treatment
- Injection or infusion
- How many people
- 14,500 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Sep 2031
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Main project (NSCLC Stage IIIB/C, Stage IV, BSC; 2015-2025): Up to 12000 patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. NSCLC stage IV (starting 2025): Up to 5000 patients with stage IV NSCLC at the start of first-line systemic therapy. Satellite NSCLC stage I-III: Up to 1600 patients with stage I-III NSCLC at the start of first antitumoral treatment (surgery, radio(chemo)therapy, systemic therapy). Satellite SCLC: Up to 2300 patients with SCLC (limited stage (LD) or extensive stage (ED)), if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, will be recruited (CRISP satellite SCLC patients). Patients will be recruited in up to 220 study sites (certified lung cancer centers, comprehensive cancer centers, hospitals and office-based oncology practices) in Germany.
Who may be able to join
- Patients who meet all of the following criteria are eligible for the project:
- Age ≥ 18 years
- Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments
- Main project (NSCLC Stage IV):
- Confirmed non-small cell lung cancer (NSCLC)
- Stage IV (UICC8)
Show all 17Show fewer
- Systemic therapy
- Informed consent no later than four weeks after start of first-line systemic treatment
- Satellite NSCLC Stage I-III:
- Confirmed non-small cell lung cancer (NSCLC)
- Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or if first treatment is surgery no longer than 3 months after start of surgery.
- Stage I-III (UICC8)
- Systemic (chemo)therapy and/or radiation therapy and/or surgery
- Satellite SCLC
- Confirmed Small cell lung cancer (SCLC)
- Informed consent no later than four weeks after start of first anti-tumor treatment
- Systemic (chemo)therapy and/or radiation therapy and/or surgery
Who cannot join
- none
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
Pius-Hospital
Oldenburg, 26121
F. Griesinger, Prof., +49 441 229 1611, Frank.griesinger@pius-hospital.de
About this study
Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany
Read the detailed description
Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-life practice, is crucial to evaluate and improve the quality of care for patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
The purpose of CRISP is to set up a national clinical research platform to document uniform data on the molecular testing, treatment, course of disease in patients with NSCLC or SCLC. A particular focus is on molecular biomarker testing before the start of first-line treatment of patients with advanced or metastatic NSCLC. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved.
PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients with NSCLC or SCLC in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC.
Furthermore, CRISP will set up a decentralized clinically annotated tissue repository for future collaborative, investigational scientific biomarker testing.
- Conditions
- Metastatic Non-small Cell Lung Cancer (NSCLC), Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage II, Non Small Cell Lung Cancer Stage III, Small-cell Lung Cancer, Non-small Cell Lung Cancer Stage I
- Being tested
- data collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Baseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC, Non-squamous cell carcinoma | Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.
At least 3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP) Receives: Other: data collection | |
| NSCLC, Squamous cell carcinoma | Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.
At least 1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP) Receives: Other: data collection | |
| NSCLC, Non-squamous cell carcinoma (not tested) | Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.
Up to 5,000 patients not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).). Receives: Other: data collection | |
| NSCLC, Stage I/II/III (2018-2023) | Up to 2400 patients with NSCLC stage I, or stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy, or are receiving best supportive care Receives: Other: data collection | |
| Small cell lung cancer (SCLC) | Up to 2300 patients with SCLC (limited stage (LD) or extensive stage (ED)) if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, or are receiving best supportive care Receives: Other: data collection | |
| NSCLC stage I-III (starting 2026) | Up to 1600 patients with stage I-III NSCLC at the start of first antitumoral treatment (surgery, radio(chemo)therapy, systemic therapy). Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarker
To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment
Measured: 3 years
treatment
To describe systemic treatments and sequential treatments applied in real-life practice
Measured: 3 years
Response rate
To assess effectiveness of systemic treatments in regards to response rate.
Measured: 3 years
progression free survival
To assess effectiveness of systemic treatments in regards to progression free survival.
Measured: 3 years
overall survival
To assess effectiveness of systemic treatments in regards overall survival.
Measured: 3 years
physician-reported factors
To describe physician-reported factors affecting treatment decision making besides biomarker profiling
Measured: 3 years
supportive therapies
to collect key data on specific supportive therapies
Measured: 3 years
changes during the project
To investigate changes in diagnostics, treatment or outcome during the course of the project
Measured: 3 years
general health-related and individual quality of life (QoL) patient-reported outcomes
To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL). and depression, (4) patient-caregiver communication
Measured: 3 years
physical and psychological well-being patient-reported outcomes
To evaluate patient-reported outcomes concerning physical and psychological well-being.
Measured: 3 years
anxiety patient-reported outcomes
To evaluate patient-reported outcomes concerning anxiety.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non-small Cell Lung Cancer (NSCLC)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Celgene Corporation, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, iOMEDICO AG, Eli Lilly and Company, Roche Pharma AG, Takeda, Amgen, Janssen-Cilag G.m.b.H, GlaxoSmithKline, Regeneron Pharmaceuticals, Astellas Pharma Global Development, Inc., Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Daiichi Sankyo Deutschland GmbH, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Frank Griesinger, Prof. Dr., Principal investigator, Pius-Hospital Oldenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622581
- Sponsor's protocol ID
- AIO-TRK-0315
- Acronym
- CRISP
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2015
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Sebastian M, Eberhardt WEE, von der Heyde E, Dorfel S, Wiegand J, Schiefer C, Losem C, Janicke M, Fleitz A, Zacharias S, Kaiser-Osterhues A, Hipper A, Dietel C, Bleckmann A, Benkelmann R, Boesche M, Grah C, Muller A, Griesinger F, Thomas M; CRISP Registry Group. Patient-reported outcomes in advanced NSCLC before and during the COVID-19 pandemic: Real-world data from the German prospective CRISP Registry (AIO-TRK-0315). Int J Cancer. 2024 Jun 1;154(11):1967-1978. doi: 10.1002/ijc.34868. Epub 2024 Feb 8.
PubMed 38329180Metzenmacher M, Griesinger F, Hummel HD, Elender C, Schafer H, de Wit M, Kaiser U, Kern J, Janicke M, Spring L, Zacharias S, Kaiser-Osterhues A, Groth A, Hipper A, Zaun G, Dorfel S, Guldenzoph B, Muller L, Uhlig J, Thomas M, Sebastian M, Eberhardt WEE; CRISP Registry Group. Prognostic factors in nonsmall cell lung cancer: insights from the German CRISP registry. Eur Respir J. 2023 Feb 2;61(2):2201336. doi: 10.1183/13993003.01336-2022. Print 2023 Feb.
PubMed 36180086Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Buttner R, Marschner N, Janicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, Thomas M; CRISP Registry Group. Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer. 2021 Feb;152:174-184. doi: 10.1016/j.lungcan.2020.10.012. Epub 2020 Nov 2.
PubMed 33358484
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
- ClinicalTrials.gov ID
- NCT02622581
- Acronym / sponsor ID
- CRISP / AIO-TRK-0315
- Conditions
- Metastatic Non-small Cell Lung Cancer (NSCLC), Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage II, Non Small Cell Lung Cancer Stage III, Small-cell Lung Cancer, Non-small Cell Lung Cancer Stage I
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 14,500 participants (estimated)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- AstraZeneca, Celgene Corporation, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, iOMEDICO AG, Eli Lilly and Company, Roche Pharma AG, Takeda, Amgen, Janssen-Cilag G.m.b.H, GlaxoSmithKline, Regeneron Pharmaceuticals, Astellas Pharma Global Development, Inc., Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Daiichi Sankyo Deutschland GmbH, Gilead Sciences
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 4 Dec 2015 (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.
Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany
Detailed description
Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-life practice, is crucial to evaluate and improve the quality of care for patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
The purpose of CRISP is to set up a national clinical research platform to document uniform data on the molecular testing, treatment, course of disease in patients with NSCLC or SCLC. A particular focus is on molecular biomarker testing before the start of first-line treatment of patients with advanced or metastatic NSCLC. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved.
PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients with NSCLC or SCLC in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC.
Furthermore, CRISP will set up a decentralized clinically annotated tissue repository for future collaborative, investigational scientific biomarker testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NSCLC, Non-squamous cell carcinoma | – | Other: data collectionPatients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. At least 3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP) |
| NSCLC, Squamous cell carcinoma | – | Other: data collectionPatients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. At least 1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP) |
| NSCLC, Non-squamous cell carcinoma (not tested) | – | Other: data collectionPatients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. Up to 5,000 patients not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).). |
| NSCLC, Stage I/II/III (2018-2023) | – | Other: data collectionUp to 2400 patients with NSCLC stage I, or stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy, or are receiving best supportive care |
| Small cell lung cancer (SCLC) | – | Other: data collectionUp to 2300 patients with SCLC (limited stage (LD) or extensive stage (ED)) if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, or are receiving best supportive care |
| NSCLC stage I-III (starting 2026) | – | Other: data collectionUp to 1600 patients with stage I-III NSCLC at the start of first antitumoral treatment (surgery, radio(chemo)therapy, systemic therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Main project (NSCLC Stage IIIB/C, Stage IV, BSC; 2015-2025): Up to 12000 patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. NSCLC stage IV (starting 2025): Up to 5000 patients with stage IV NSCLC at the start of first-line systemic therapy. Satellite NSCLC stage I-III: Up to 1600 patients with stage I-III NSCLC at the start of first antitumoral treatment (surgery, radio(chemo)therapy, systemic therapy). Satellite SCLC: Up to 2300 patients with SCLC (limited stage (LD) or extensive stage (ED)), if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, will be recruited (CRISP satellite SCLC patients). Patients will be recruited in up to 220 study sites (certified lung cancer centers, comprehensive cancer centers, hospitals and office-based oncology practices) in Germany.
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments
- Confirmed non-small cell lung cancer (NSCLC)
- Stage IV (UICC8)
- Systemic therapy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| data collectionBaseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months. | Other | NSCLC stage I-III (starting 2026), NSCLC, Non-squamous cell carcinoma, NSCLC, Non-squamous cell carcinoma (not tested), NSCLC, Squamous cell carcinoma, NSCLC, Stage I/II/III (2018-2023), Small cell lung cancer (SCLC) |
Primary outcome
biomarker
Time frame: 3 years
To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment
treatment
Time frame: 3 years
To describe systemic treatments and sequential treatments applied in real-life practice
Response rate
Time frame: 3 years
To assess effectiveness of systemic treatments in regards to response rate.
progression free survival
Time frame: 3 years
To assess effectiveness of systemic treatments in regards to progression free survival.
overall survival
Time frame: 3 years
To assess effectiveness of systemic treatments in regards overall survival.
physician-reported factors
Time frame: 3 years
To describe physician-reported factors affecting treatment decision making besides biomarker profiling
supportive therapies
Time frame: 3 years
to collect key data on specific supportive therapies
changes during the project
Time frame: 3 years
To investigate changes in diagnostics, treatment or outcome during the course of the project
general health-related and individual quality of life (QoL) patient-reported outcomes
Time frame: 3 years
To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL). and depression, (4) patient-caregiver communication
physical and psychological well-being patient-reported outcomes
Time frame: 3 years
To evaluate patient-reported outcomes concerning physical and psychological well-being.
anxiety patient-reported outcomes
Time frame: 3 years
To evaluate patient-reported outcomes concerning anxiety.
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 9 Oct 2026.
- Derived from this study: PubMed 38329180Sebastian M, Eberhardt WEE, von der Heyde E, Dorfel S, Wiegand J, Schiefer C, Losem C, Janicke M, Fleitz A, Zacharias S, Kaiser-Osterhues A, Hipper A, Dietel C, Bleckmann A, Benkelmann R, Boesche M, Grah C, Muller A, Griesinger F, Thomas M; CRISP Registry Group. Patient-reported outcomes in advanced NSCLC before and during the COVID-19 pandemic: Real-world data from the German prospective CRISP Registry (AIO-TRK-0315). Int J Cancer. 2024 Jun 1;154(11):1967-1978. doi: 10.1002/ijc.34868. Epub 2024 Feb 8.
- Derived from this study: PubMed 36180086Metzenmacher M, Griesinger F, Hummel HD, Elender C, Schafer H, de Wit M, Kaiser U, Kern J, Janicke M, Spring L, Zacharias S, Kaiser-Osterhues A, Groth A, Hipper A, Zaun G, Dorfel S, Guldenzoph B, Muller L, Uhlig J, Thomas M, Sebastian M, Eberhardt WEE; CRISP Registry Group. Prognostic factors in nonsmall cell lung cancer: insights from the German CRISP registry. Eur Respir J. 2023 Feb 2;61(2):2201336. doi: 10.1183/13993003.01336-2022. Print 2023 Feb.
- Derived from this study: PubMed 33358484Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Buttner R, Marschner N, Janicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, Thomas M; CRISP Registry Group. Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer. 2021 Feb;152:174-184. doi: 10.1016/j.lungcan.2020.10.012. Epub 2020 Nov 2.
- AIO - Working Group for Medical Oncology from the German Cancer SocietyLink provided by the sponsor.
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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.
Frank Griesinger, Prof. Dr. principal investigator
Pius-Hospital Oldenburg
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 Metastatic Non-small Cell Lung Cancer (NSCLC) and Non-small Cell Lung Cancer Metastatic, run by AIO-Studien-gGmbH 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 17 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: looking for participants now, as of the sponsor's last update on 9 Oct 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 Annika Groth (+49 30-8145344-39, annika.groth@aio-studien-ggmb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarker (time frame: 3 years). The study lists 11 primary outcomes in all. 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 NCT02622581, which also lists 3 linked publications.
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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.