Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:53 PM
Study NCT ID:
NCT07432932
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D006394', 'term': 'Hemangiosarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biopsy specimen, surgical specimen, blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone', 'timeFrame': 'Through study completion, average 4 years'}, {'measure': 'Develop an understanding of radiomic profiles for patients treated with NCT.', 'timeFrame': 'Through study completion, average 4 years'}, {'measure': 'Develop an electronic STS Tissue Atlas for 5 high risk subtypes.', 'timeFrame': 'Through study completion, average 4 years'}, {'measure': 'Develop and characterize patient derived models to investigate biology of high-risk sarcomas and directly test predicted therapeutic interventions', 'timeFrame': 'Through study completion, average 4 years'}, {'measure': 'Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.', 'timeFrame': 'Through study completion, average 4 years'}], 'secondaryOutcomes': [{'measure': 'To assess whether there is a difference in metastases-free survival (MFS), recurrence free survival (RFS) and overall survival (OS) between patients with high risk STS who receive NCT compared to those who do not receive NCT', 'timeFrame': 'Through study completion, average 4 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PANTHRS', 'PANTHRS-S', 'Sarcoma Accelerator'], 'conditions': ['Sarcoma', 'Sarcoma, Leiomyo-, Adult', 'Sarcoma, Synovial, Adult', 'Soft Tissue Sarcoma (STS)', 'Soft Tissue Sarcoma Adult', 'Soft Tissue Sarcoma of the Trunk and Extremities', 'Soft Tissue Sarcoma of the Limb', 'Retroperitoneal Sarcoma', 'Liposarcoma, Dedifferentiated', 'Liposarcoma', 'Leiomyosarcoma (LMS)', 'Angiosarcoma']}, 'descriptionModule': {'briefSummary': 'This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.', 'detailedDescription': 'This is a multi-centre collaborative study across four countries which aims to accelerate precision medicine approaches for neoadjuvant therapy in high risk sarcomas.\n\nThe study will include both prospective and retrospective patient identification and inclusion from two cohorts; patients who advanced to surgery alone or received surgery and NCT. The participating local centres will continue pre-approved established data and tissue collection processes. Collaboration with external sites will allow the recruitment of a larger cohort of patients to be included in analyses.\n\nPatients will be recruited for the study from each of the following five centres: The Royal Marsden Hospital, The Beatson West of Scotland Centre Glasgow, Birmingham NHS Trust, Fondazione IRCCS Istituto Nazionale dei Tumori and Hospital Universitario Virgen del Rocio/Instituto de Biomedicina de Sevilla.\n\nTranslational research analysis will be undertaken at all three centres. Pseudonymised clinical data and tissue samples from each centre will be sent to the centre responsible for the specific component of the project. The transfer of material and data will be undertaken in accordance with Human Tissue Authority (HTA) regulation, and appropriate MTAs will be put in place prior to the transfer of any tissue between sites. A data protection checklist will also be completed and reviewed by the information governance team of each institution to ensure all pseudonymised data shared by collaborating sites is dealt with appropriately and adheres to the responsibilities of each institution relating to patient confidentiality and appropriate data handling practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with one of DDLPS, LMS, SS, vascular sarcomas or MPNST either advancing directly to surgery or receiving neoadjuvant chemotherapy and surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent for the prospective cohort\n\n * Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.\n * High-risk sarcoma definition:\n\n * Greater than 5cm or Grade 3\n * Deep anatomic location\n * Have disease amenable to biopsy\n\n o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study\n * Resectable tumour\n * Measurable disease by RECIST 1.1\n * Aged ≥ 18 years\n * WHO performance status 0-2\n * For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy\n * Patients medically fit enough to undergo surgical resection\n * Capable of giving written informed consent (for prospective cohort) and comply with the study schedule\n * Patients may also participate in the STRASS 2 trial\n\nExclusion Criteria:\n\n-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.\n\n* Known additional malignancy that is progressing or requires active treatment\n* Metastatic disease not amenable to curative intent local therapy\n* Any active uncontrolled medical conditions'}, 'identificationModule': {'nctId': 'NCT07432932', 'acronym': 'PANTHR-S', 'briefTitle': 'Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients', 'orgStudyIdInfo': {'id': 'CCR 5337'}, 'secondaryIdInfos': [{'id': '2021-001437-39', 'type': 'EUDRACT_NUMBER'}, {'id': '286407', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective', 'description': 'Prospective observational cohort study: a cohort of patients advancing directly to surgery ("Control group") and Prospective cohort receiving neo-adjuvant chemotherapy. Prospectively enrolled patients with STS, tissue samples pre-chemotherapy and from surgical resection will undergo epigenetic, proteomic and genomic profiling to define the biology at two distinct time points.', 'interventionNames': ['Other: Observational Translational Study']}, {'label': 'Retrospective', 'description': 'Retrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT.', 'interventionNames': ['Other: Observational Translational Study']}], 'interventions': [{'name': 'Observational Translational Study', 'type': 'OTHER', 'description': 'Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)', 'armGroupLabels': ['Prospective', 'Retrospective']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stephanie Elston', 'role': 'CONTACT', 'email': 'PANTHRS.Trial@rmh.nhs.uk', 'phone': '02073528171'}], 'facility': 'The Royal Marsden Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Stephanie Elston, MSc', 'role': 'CONTACT', 'email': 'PANTHRS.Trial@rmh.nhs.uk', 'phone': '02073528171'}, {'name': 'Thuy-Giang Nguyen, BSc', 'role': 'CONTACT', 'email': 'PANTHRS.Trial@rmh.nhs.uk', 'phone': '02073528171'}], 'overallOfficials': [{'name': 'Robin Jones, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, {'name': 'University of Edinburgh', 'class': 'OTHER'}, {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, {'name': 'University of Birmingham', 'class': 'OTHER'}, {'name': 'University Hospital Birmingham', 'class': 'OTHER'}, {'name': 'Cancer Research UK', 'class': 'OTHER'}, {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Andalusian Network for Design and Translation of Advanced Therapies', 'class': 'OTHER'}, {'name': 'Instituto de Biomedicina de Sevilla', 'class': 'UNKNOWN'}, {'name': 'the Fundación Científica de la Asociación Española Contra el Cáncer', 'class': 'UNKNOWN'}, {'name': 'Associazione Italiana per la Ricerca sul Cancro', 'class': 'OTHER'}, {'name': 'Freeman Hospital, UK', 'class': 'UNKNOWN'}, {'name': 'Liverpool Hospital', 'class': 'UNKNOWN'}, {'name': 'The Clatterbridge Cancer Centre NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}