Solid TumorNCT03517917
Prospective Tissue Collection Research Protocol
An observational study of Solid Tumor, run by AstraZeneca at 18 sites in 3 countries.
Trial summary
This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Tumour tissue collection
- How many people
- 221 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 8 Feb 2018to 8 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid tumour scheduled for either biopsy or resection of their tumour(s) as part of their standard of care, and patients with superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.
Who may be able to join
- Aged ≥ 18 years
- Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation.
- Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease.
- Patient is scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy, has a superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.
- Haemoglobin(Hb) ≥ 10g/dL without transfusion support for at least 3 weeks (for patients donating whole blood).
- White cell count ≥ 3 x 10^9/L (for patients donating whole blood).
- For selected solid tumours and leukapheresis procedure additional inclusion criteria apply.
Who cannot join
- Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue.
- Inadequate peripheral venous access precluding collection of blood.
- Pregnant or breastfeeding women.
- Known/laboratory confirmed diagnosis of an active infectious disease to include Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis.
- Patients who are currently participating in a clinical trial involving an unlicensed medical product.
- Patients who have received any cytotoxic therapy (including investigational products) within three weeks prior to tissue procurement.
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- Patients receiving immunosuppressive treatments or who require regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).
- Any medical reason why, in the opinion of the investigator, the patient should not participate in this study.
- For selected solid tumours and leukapheresis procedure additional exclusion criteria apply.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United Kingdom11 sites
Research Site
Glasgow, G51 4TF
Research Site
Leeds, LS9 7TF
Research Site
London, NW1 2PG
Research Site
London, NW3 2QG,
Research Site
London, SE1 9RT
Research Site
London, SW3 6JJ
Research Site
London, SW3 6NP
Research Site
Manchester, M23 9LT
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Southampton, SO16 6YD
Research Site
Uxbridge, UB9 6JH
Spain4 sites
Research Site
Barcelona, 08036
Research Site
Barcelona, 08908
Research Site
Madrid, 28040
Research Site
Madrid, 28050
United States3 sites
Research Site
Durham, North Carolina, 27710
Research Site
Georgetown, Washington, 20057
Research Site
New York, New York, 10065
About this study
Official title: Prospective Collection of Donor Tissue and Whole Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)
This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies.
Read the detailed description
During standard of care surgery tumour samples which are surplus to the requirements of the patients diagnostic/treatment pathway will be procured along with a matched whole blood and/or leukapheresis sample. In some instances patients may consent to provide a non-standard of care, non-invasive research biopsy.
Within 28-42 days following procurement of samples patients will be required to participate in a safety follow up call for assessment of any procedure related adverse events.
- Conditions
- Solid Tumor
- Being tested
- Tumour tissue collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour tissue collectionOther
Collection of tumour tissue and blood
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Tumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed. Receives: Other: Tumour tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining samples for research
This protocol does not have an analysis primary outcome measure. It will be conducted in accordance with the principles of Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start8 Feb 2018
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517917
- Sponsor's protocol ID
- ATX-MAP-001
- Status last verified
- May 2025
- First submitted
- 25 Apr 2018
- Last updated
- 23 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Donor Tissue and Whole Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)
- ClinicalTrials.gov ID
- NCT03517917
- Acronym / sponsor ID
- ATX-MAP-001
- Conditions
- Solid Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 8 May 2018 (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.
This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies.
Detailed description
During standard of care surgery tumour samples which are surplus to the requirements of the patients diagnostic/treatment pathway will be procured along with a matched whole blood and/or leukapheresis sample. In some instances patients may consent to provide a non-standard of care, non-invasive research biopsy.
Within 28-42 days following procurement of samples patients will be required to participate in a safety follow up call for assessment of any procedure related adverse events.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: Tumour tissue collectionTumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumour scheduled for either biopsy or resection of their tumour(s) as part of their standard of care, and patients with superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.
Key inclusion criteria (7 listed)
- Aged ≥ 18 years
- Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation.
- Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease.
- Patient is scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy, has a superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.
- Haemoglobin(Hb) ≥ 10g/dL without transfusion support for at least 3 weeks (for patients donating whole blood).
Key exclusion criteria (9 listed)
- Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue.
- Inadequate peripheral venous access precluding collection of blood.
- Pregnant or breastfeeding women.
- Known/laboratory confirmed diagnosis of an active infectious disease to include Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis.
- Patients who are currently participating in a clinical trial involving an unlicensed medical product.
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 |
|---|---|---|
| Tumour tissue collectionCollection of tumour tissue and blood | Other | Arm 1 |
Primary outcome
Obtaining samples for research
Time frame: 5 years
This protocol does not have an analysis primary outcome measure. It will be conducted in accordance with the principles of Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Privacy DataLink 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by AstraZeneca at 18 sites in 3 countries.
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 9 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: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom, Spain, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obtaining samples for research (time frame: 5 years). 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 23 May 2025.