Female Breast CancerPROOFSNCT05792150
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
An observational study of Female Breast Cancer, run by Women's Cancer Study Group GmbH at 71 sites in Germany.
Trial summary
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Breast Cancer
- How many people
- 1,470 participants
- Where
- 71 sitesGermany
- Study dates
- 7 Dec 2022to Jun 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: For this registry, it is planned to screen N=3000 pre- and perimenopausal patients with early breast cancer who meet the inclusion criteria, i.e., intermediate to high clinical risk for recurrence, and who will receive or have received a routine genomic testing by MammaPrint® with a low/ultralow genomic risk. It is anticipated that 75% of these patients will be nodal negative and 25% nodal positive.
Who may be able to join
- Patients are eligible for participation in the registry only if they meet all the following criteria:
- Female breast cancer patients
- Pre- or perimenopausal at registry entry (age <60 years and state after hysterectomy or amenorrhea for <12 months; confirmation by blood hormone levels (FSH and estradiol in premenopausal range as per local normal range) recommended)
- Primary tumor diagnosis not older than three months prior to inclusion (primary diagnosis defined as date of initial tumor biopsy)
- Estrogen- and/or progesterone-receptor-positive/HER2 negative early breast cancer without any clinical signs of metastases
- Adequate risk for recurrence:
Show all 23Show fewer
- intermediate clinical risk for recurrence, defined as (clinical in case of neoadjuvant treatment):
- c/pT1 and
- c/pN0 and
- Ki-67 15-24% or
- G2 or
- patients, who do not meet these criteria but are at intermediate clinical risk for recurrence at investigator decision (e.g., very young age, low expression of hormone receptors, existing co-morbidities, familial cancer burden, etc.) can be included on individual decision basis or
- high clinical risk for recurrence, defined as either (clinical in case of neoadjuvant treatment):
- c/pT2-4 or
- c/pN1 or
- Ki-67 ≥25% or
- G3
- Low genomic risk of recurrence by MammaPrint® (tested on treatment naïve tumor specimen)
- Luminal-type by BluePrint®
- Treatment according to standard-of-care (e.g., AGO Guidelines) planned or started (until completion of local therapy the latest (including started or completed endocrine induction therapy), started, or planned adjuvant or neoadjuvant treatment)
- Availability of untreated tumor material (core biopsy if preoperative endocrine therapy performed or neoadjuvant treatment intended or surgery specimen)
- Capability to give written informed consent
- Nodal positive patients will be accepted to the registry up to 25% of the genomic low/ultralow-risk population (n=441).
Who cannot join
- Patients will not be eligible for the registry for any of the following reasons:
- Any other genomic testing, besides MammaPrint®, has been performed on the tumor material
- Medical or psychological conditions that would not permit the patient to sign informed consent
- Legal incapacity or limited legal capacity
- Current participation in any interventional clinical trial which tests anticancer drugs, immunotherapeutics, or antibody treatment for any type of neoplasm
- Non-compliance of the patient
Trial locations and contacts
71 sites in 1 country. Contact the study team or a site near you to ask about taking part.
71 sites in 1 country
Germany71 sites, 61 recruiting
- Recruiting
Marienhospital Aachen
Aachen, North Rhine-Westphalia, 52066
Esther Geller, Dr. med.
Birgit Dreyer
- Recruiting
Klinikum St. Marien Amberg
Amberg, Bavaria, 9224
Tanja Hauzenberger, Dr. med
Jacqueline Roy
- Recruiting
HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg
Augsburg, Bavaria, 86150
Bernhard Heinrich, Dr. med.
Karin Hillgardt
- Recruiting
Universitätsklinikum Augsburg, Brustzentrum
Augsburg, Bavaria, 86156
Nina Ditsch, Prof. Dr.
Sonja Dannecker
- Recruiting
Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim
Bad Nauheim, Hesse, 61231
Martin Hellriegel, Dr. med.
Anne Groß
- Recruiting
Gynäkologische- Geburtshilfliche Klinik
Bad Soden am Taunus, Hesse, 65812
Johannes Lecht, Dr.
Susanne Hegner, Dpl.
- Recruiting
Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum
Baden-Baden, Baden-Wurttemberg, 76532
Antje Hahn, Dr. med.
Martina Koch
- Recruiting
Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe
Berlin, Brandenburg, 14089
Jessica Groß, Dr
Antje Merkle
- Active, not recruiting
Medionko - Praxisklinik Krebsheilkunde Frauen
Berlin, State of Berlin, 10367
- Recruiting
St. Gertrauden Krankenhaus Brustzentrum City Berlin
Berlin, State of Berlin, 10713
Lidia Perlova-Griff
Michaela Platzer
- Recruiting
DRK Kliniken Berlin Köpenick
Berlin, State of Berlin, 12559
Anke Kleine-Tebbe, Dr. med.
Manuela Rösler
- Active, not recruiting
Gynäkologisches Zentrum
Bonn, North Rhine-Westphalia, 53111
- Active, not recruiting
Universitätsklinikum Bonn Frauenheilkunde
Bonn, North Rhine-Westphalia, 53127
- Recruiting
Universitätsklinikum Bonn, Senologie
Bonn, North Rhine-Westphalia, 53127
Anne Bachmann
Judith Sailler
- Recruiting
Marienhospital, Klinik für Gynäkologie und Geburtshilfe
Bottrop
Hans-Christian Kolberg, PD Dr.
Jessica Zeller
- Recruiting
Hämatologie/Onkologie Praxis
Bremen, Free Hanseatic City of Bremen, 28209
Ralf Meyer, Dr. med.
Heike Munzinger, Dr. nat.
- Recruiting
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
Bremen, Free Hanseatic City of Bremen, 28239
Barbara Baloniak, Dr.
Monika Tietze
- Recruiting
Klinikum Bremerhaven Reinkenheide
Bremerhaven, Free Hanseatic City of Bremen, 27574
Amelie Bletscher
Marcelle Lagemann
- Active, not recruiting
Medias Klinikum
Burghausen, Bavaria, 84489
- Recruiting
Kliniken der Stadt Köln
Cologne, North Rhine-Westphalia, 51067
Katharina Weinhold, Dr. med.
Claudia Weise
- Recruiting
St. Vincenz-Krankenhaus Datteln
Datteln, North Rhine-Westphalia, 45711
Saskia Hornberg, Dr.
Silvia Schneider
- Recruiting
Klinikum Dortmund gGmbH, Beurhausstr.40
Dortmund, North Rhine-Westphalia, 44137
Claudia Biehl
Jacqueline Aschhoff
- Recruiting
Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum
Duisburg, North Rhine-Westphalia, 47053
Katja Engellandt, Dr. med.
Antje auf dem Keller
- Recruiting
Luisenkrankenhaus GmbH Co KG
Düsseldorf, North Rhine-Westphalia, 40235
Athina Kostara, Dr. med.
Anne Huelsewiesche
- Recruiting
Marien Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40479
Jens-Peter Kruse
David Tschirch
- Active, not recruiting
Universitätsklinikum Erlangen
Erlangen, Erlangen, 91054
- Recruiting
Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum
Essen, North Rhine-Westphalia, 45136
Sherko Kümmel, Prof.Dr
Dorothea Schindowski
- Recruiting
Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum
Fürstenfeldbruck, Bavaria, 82256
Konstanze Türpe
Mandy Merwerth
- Recruiting
St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)
Goch, North Rhine-Westphalia, 47574
Volker Runde, Prof. Dr.
Elke Beeker-Cornelissen
- Recruiting
AGAPLESION Allgemeines Krankenhaus Hagen
Hagen, North Rhine-Westphalia, 58095
Nurhayat Yurtcu, Dr.
Tamara Sitnikow
- Recruiting
Krankenhaus St. Elisabeth und St. Barbara Halle/Saale
Halle, Saxony-Anhalt, 06110
Tilmann Lantzsch, Dr. med.
Mandy Babbe
- Recruiting
AGAPLESION Diakonie Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20259
Mustafa Celalettin Ugur, Dr.
Mirjam Ahrens
- Recruiting
Gynäkologische Praxisklinik Hamburg-Harburg
Hamburg, Free and Hanseatic City of Hamburg, 21073
Christoph Großmann, Dr. med.
Belma Salihadgic
- Recruiting
Asklepios Klinik Barmbek
Hamburg, Free and Hanseatic City of Hamburg, 22307
Katharina Maria Seiffert, Dr.med.
Sabine Drießelmann
- Recruiting
St. Barbara Klinik
Hamm, North Rhine-Westphalia, 59073
Claudia Strunk, Dr.
Gabriele Kerkmann
- Active, not recruiting
Klinikum Hanau GmbH
Hanau, Hesse, 63450
- Recruiting
DIAKOVERE Henriettenstift
Hanover, Lower Saxony, 30171
Kristina Lübbe, Dr.
Laura Alina Löffler
- Recruiting
Altmark- Klinikum
Hansestadt Salzwedel, Saxony-Anhalt, 29410
Susanne Kraudelt, Dr.
Steffi Mack-Eichner
- Recruiting
Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH
Herdecke, North Rhine-Westphalia, 58313
Hanne- Kathrin Bracht
Jasmin Schiprowski
- Recruiting
Ärztehaus am Bahnhofsplatz
Hildesheim, Lower Saxony, 31134
Christopher Uleer, Dr.
Andrea Meyer-Kühn
- Recruiting
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Baden-Wüttemberg, 76135
Oliver Tomé, Dr.
- Recruiting
Elisabethkrankenhaus Kassel, Brustzentrum
Kassel, Hesse, 34117
Sabine Schmatloch, Dr. med.
Ivonne Kurzhals
- Recruiting
Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung
Krefeld
Maria Marina Wirtz, Dr. med.
Laura Mengel
- Recruiting
Studienzentrum Untere Ems
Leer, Lower Saxony, 26789
Lothar Müller, Dr. med
Christine Strohschnieder
- Recruiting
Klinikum Leverkusen, Am Gesundheitspark
Leverkusen, North Rhine-Westphalia, 51375
Andrea Heider, Dr.
Katja Pöggel-Krämer
- Recruiting
Klinikum Luckenwalde
Luckenwalde, Brandenburg, 14943
Benedikt Lotz, Dr
Orfea-Graziella Zehm
- Recruiting
Katholisches Klinikum Lünen/Werne
Lünen, North Rhine-Westphalia, 44534
Donat Romann, Dr.
Ute Heine
- Active, not recruiting
Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum
Marburg, Hesse, 35043
- Recruiting
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Mönchengladbach, North Rhine-Westphalia, 41061
Oleg Gluz, PD Dr.
Carolin Sydlik
- Recruiting
Klinikum der Universität München
München, Bavaria, 80336
Nadia Harbeck, Prof. Dr.
Beate Rank
- Active, not recruiting
Med. Zentrum f. Hämatologie und Onkologie München
München, Bavaria, 80639
- Recruiting
St. Franziskus-Hospital
Münster, North Rhine-Westphalia, 48145
Christian Eichler, PD Dr.
Sarah Damerau
- Recruiting
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149
Joke Tio, Dr.
Stefanie Nienkemper
- Recruiting
Onkologische Praxis Oldenburg, Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie
Oldenburg, Lower Saxony, 26121
Daniel Reschke, Dr.
Antje Reschke
- Recruiting
Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH
Paderborn, North Rhine-Westphalia, 33098
Michael-Patrick Lux, Prof. Dr.
Sara Heimann
- Recruiting
Helios Klinikum Pforzheim, Brustzentrum
Pforzheim, Baden-Wurttemberg, 75175
Renu Buss-Steidle, Dr.
Dana Ruppert
- Recruiting
Studienzentrum Onkologie Ravensburg
Ravensburg, Baden-Wüttemberg, 88212
Thomas Decker, Prof. Dr.med
Irina Gossen
- Recruiting
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe
Regensburg, Bavaria, 93053
Stephan Seitz, Dr.
Cornelia Lämmel
- Recruiting
Mathias-Spital-Rheine
Rheine, North Rhine-Westphalia, 48431
Sebastian Bröckling, Dr. med.
Denise Ernst
- Recruiting
Klinikum Südstadt
Rostock, Mecklenburg-Vorpommern, 18059
Kristin Strauß, Dr.
Michaela Stecher
- Active, not recruiting
MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)
Schwerte
- Active, not recruiting
Diakonieklinikum Stuttgart, Brustzetrum
Stuttgart, Baden-Wurttemberg, 70176
- Recruiting
Klinikum Traunstein, Frauenklinik Südostbayern
Traunstein
Christian Schindlbeck, Prof. Dr.
Christina Greil
- Recruiting
Praxisnetzwerk Hämatologie/int. Onkologie
Troisdorf, North Rhine-Westphalia, 53840
Helmut Forstbauer, Dr. med.
Stefanie Vorpahl
- Recruiting
Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe
Ulm, Baden-Wurttemberg, 89075
Brigitte Rack, Prof. Dr.
Mirela Karic
- Recruiting
Christliches Klinikum Unna gGmbH
Unna, North Rhine-Westphalia, 59423
Cristin Kühn, Dr. med.
Vanessa Schuster
- Recruiting
GRN Klinik Weinheim/ Gynäkologie/Brustzentrum
Weinheim, Baden-Wurttemberg, 69469
Lelia Bauer, Dr. med.
Snjezana Stein
- Recruiting
Evangelisches Krankenhaus Wesel GmbH
Wesel, North Rhine-Westphalia, 46485
Daniela Rezek, Dr. med.
Shqipe Lorito
- Recruiting
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, Hesse, 65189
Antje Lehnert, Dr. med.
Andrea Lunkenheimer
- Recruiting
Klinikum Worms
Worms, Rhineland-Palatinate, 67550
Antje Nixdorf, Dr. med.
Tanja Knoll
- Recruiting
Helios Klinikum Wuppertal
Wuppertal, North Rhine-Westphalia, 42283
Vesna Bjelic-Radisic, Prof. Dr.
Manuela Smiljanic
About this study
Official title: Real World Data and Long-term FU of Pre-/Perimenopausal Women With Luminal EBC With Intermediate to High Clinical and Low Genomic Recurrence-risk Measured by MammaPrint®, Treated by SOC ET+OFS or SOC Chemotherapy Treatment Followed by ET
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively. The WSG ADAPT trial data on the impact of postmenopausal status and/or use of OFS within 3-4 weeks endocrine induction therapy show relevant impact of OFS/postmenopausal status on Ki-67 response; also, secondary amenorrhea after (neo-)adjuvant chemotherapy was a positive predictor of outcome due to OFS [8, 9].
This registry will give insights in the real-world use of OFS and the effect of secondary amenorrhea in female pre- and perimenopausal patients with or without previous use of chemotherapy and with different endocrine treatments (ET +/- GnRH).
Read more
As adherence over time (5-10 years) plays a major role in the endocrine treatment, the registry will follow patients' treatments for up to 10 years and include QoL information.
Results of MammaPrint® (MammaPrint® Index) as indicating factor for chemotherapy use and risk classification, thus, choice of adjuvant treatment (chemotherapy, OFS combined with endocrine therapy, or endocrine therapy alone) will be correlated to outcome under real-world conditions.
Baseline, treatment, and relapse data shall be collected to gain further insight in the treatment paths, treatment adherence, and outcome of such patients.
Read the detailed description
This registry aims
- to confirm an excellent outcome in pre-/perimenopausal patients treated by endocrine therapy (+ ovarian suppression) in patients with low genomic risk by MammaPrint® without chemotherapy use in a real-world setting.
- to evaluate management of ovarian function in patients treated by adjuvant chemotherapy according to investigator decision.
- to evaluate adherence to endocrine therapy (+/- ovarian function suppression).
- to evaluate the prognostic impact of clinicopathological markers (e.g., estrogen receptor (ER), progesterone receptor (PR), HER2 receptor, Ki-67 at baseline and after preoperative endocrine therapy (if any performed) by local pathology assessment compared to genomic signature result.
- to assess the course of quality of life (QLQ BR23 and QLQ-C30) until 5 years of treatment with OFS (Baseline, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years)
In general, WSG aim to assess the quality of surveillance care in younger breast cancer patients. WSG want to gain knowledge about endocrine induction treatment for indication of chemotherapy followed by endocrine treatment or endocrine treatment alone. Also, WSG aim at changes in duration of endocrine treatment (especially in high-risk patients up to 10 years) and introduction of intensified endocrine therapy (OFS) in combination with GnRH-analogues since publication of the SOFT and TEXT trials.
- Conditions
- Female Breast Cancer
- Keywords
- HR+, HER2-, EBC, early breast cancer, female, OFS, ET, chemotherapy
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year distant recurrence-free interval (dRFI, according to STEEP criteria version 2.0)
dRFIin all patients treated by (intensified) endocrine therapy alone (and with ovarian suppression in cases with enhanced clinical risk according to current AGO-recommendations)
Measured: 5 years
Secondary outcomes (20)
10-year dRFI
dRFI, according to STEEP criteria 2.0, in all patients treated by (intensified) endocrine therapy alone (with ovarian suppression in cases with higher clinical risk)
Measured: 10 years
5-year dRFI
dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS
Measured: 5 years
10-year dRFI
dRFI, according to STEEP criteria 2.0,in all patients treated by SOC chemotherapy treatment followed by ET+/-OFS
Measured: 10 years
5-year dDFS
distant disease-free survival (dDFS, according to STEEP 2.0) in all patients and all treatment groups (i.e., patients treated by ET alone, ET + GnRH, chemotherapy followed by ET, chemotherapy followed by ET + GnRH, OFS-treated patients)
Measured: 5 years
10-year dDFS
distant disease-free survival (dDFS, according to STEEP 2.0) in all patients and all treatment groups (i.e., patients treated by ET alone, ET + GnRH, chemotherapy followed by ET, chemotherapy followed by ET + GnRH, OFS-treated patients)treatment followed by ET+/-OFS
Measured: 10 years
5-year OS
overall survival (OS) in all patients and all treatment groups
Measured: 5 years
10-year OS
overall survival (OS) in all patients and all treatment groups
Measured: 10 years
5-year breast cancer-free interval (BCFI, according to STEEP 2.0)
BCFI in all patients and all treatment groups
Measured: 5 years
10-year breast cancer-free interval (BCFI, according to STEEP 2.0)
BCFI in all patients and all treatment groups
Measured: 10 years
EORTC quality of life questionnaire BR23
compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: every 3 months within 1st year
EORTC quality of life questionnaire C30
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
Measured: every 3 months within 1st year
EORTC quality of life questionnaire BR23
compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: every 6 months within 2nd year
EORTC quality of life questionnaire C30
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
Measured: every 6 months within 2nd year
EORTC quality of life questionnaire BR23
compare the course of Qol between baseline and further defined timepoints; 23 items, symptom scales/items and functional scales/items, all of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: yearly until 5 years
EORTC quality of life questionnaire C30
compare the course of Qol between baseline and further defined timepoints; 30 items, 10 subscales, the higher the rating, the worse.
Measured: yearly until 5 years
adherence to OFS and endocrine treatment
Duration of intake of OFS and endocrine treatment in all patients
Measured: 10 years
concordance between BluePrint®/MammaPrint® molecular subtyping results vs. pathological immune-histochemistry results
concordance between BluePrint®/MammaPrint® molecular subtyping results and pathological immune-histochemistry results with respect to tumour type
Measured: 10 years
endocrine response measured by post-endocrine Ki-67
post-endocrine Ki-67 (≤10% and/or relative change vs. baseline) in patients treated by preoperative ET
Measured: 10 years
5-year iDFS in node-negative patients with ultralow MammaPrint
node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)
Measured: 5 years
10-year iDFS in node-negative patients with ultralow MammaPrint
node-negative patients with ultralow MammaPrint® treated by shorter duration of ET (2-3 years at investigator decision)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start7 Dec 2022
- Primary completionMar 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,470 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Women's Cancer Study Group GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Agendia
- Responsible party
- Sponsor
- Investigators
- Oleg Gluz, PD Dr., Principal investigator, Westdeutsche Studiengruppe GmbHRachel Wuerstlein, Prof. Dr., Principal investigator, Westdeutsche Studiengruppe GmbHMonika Graeser, PD Dr., Study director, Westdeutsche Studiengruppe GmbHNadia Harbeck, Prof. Dr., Principal investigator, LMU Clinics, Breast Centre and CCCSherko Kuemmel, Prof. Dr., Principal investigator, KEM, Clinics Essen-MitteUlrike Nitz, Prof. Dr., Study director, Westdeutsche Studiengruppe GmbHAndreas Hartkopf, Prof. Dr., Principal investigator, Univewrsity Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792150
- Sponsor's protocol ID
- WSG-NIS04 / PROOFS
- Acronym
- PROOFS
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No