Prospective Collection Tissue Research Protocol

Solid Tumor Clinical Trial

Official title:

Prospective Collection Tissue Research Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03447522
• Other study ID #: ATX-TBL-001
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2018
• Last updated: February 26, 2018
• Start date: February 2018
• Est. completion date: February 2023

Study information

• Verified date: February 2018
• Source: Achilles Therapeutics Ltd
• Contact: Shreenal Patel, PhD
• Phone: 01438 906855
• Email: s.patel[@]achillestx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to collect matched donor tissue and blood to enable the development of a manufacturing process for potential immunotherapies.

Description:

This study intends to collect tumour tissue that would otherwise be discarded and 150 mLs of blood from consenting patients for the development of manufacturing processes for potential immunotherapies.

Suitable patients will provide consent at the first patient visit. Baseline assessments as per standard of care and a record of patient demographics will be taken for visit 1. Details will also be collected about current medical conditions and procedures and current medications. Patients will be tested for infectious diseases e.g. HIV, Human T-cell lymphotropic virus (HTLV), Hepatitis B, C and syphilis.

Visit 2: At this visit suitable patients who have met all the inclusion and exclusion criteria and have a negative infectious disease screen test result at screening will attend for either tissue sampling (take a small piece of tissue of the tumour) or tumour resection (removal of cancerous growth) whichever is the most appropriate treatment for them as dictated by the hospitals' own procedures and care pathways. The patient will also donate 150 mls of blood. This procedure is outside the standard of care.

All donated samples will be couriered to the specialist Sponsor laboratory with appropriate oversight.

Visit 3 (Day 42 ±14 days) Following standard of care procedure, patients will receive their standard follow up care. For this protocol a follow up telephone call will be made to ensure patients have recovered fully.

This then concludes the patients' participation in the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be at least 18 years old at the Screening Visit.

2. Patient has given informed consent to participate in the study

3. Suspected or confirmed diagnosis of solid tumour with either primary, recurrent or metastatic disease scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy.

4. Haemoglobin = 10g/dL

5. White cell count = 3 x 109/L

6. Negative laboratory test for blood borne pathogens (see exclusion criterion 5)

Exclusion Criteria:

1. The patient is an employee of Achilles Therapeutics

2. Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue

3. Inadequate peripheral venous access precluding collection of blood

4. Known pregnancy

5. Known/laboratory confirmed diagnosis of an infectious disease preventing inclusion of tissue into cell manufacturing suite.

As a minimum, the patient will undergo specific screening for the following infections: HIV 1 and 2, HTLV I/II, Hepatitis B, Hepatitis C, Syphilis.

6. Patients who are currently participating in a clinical trial involving an unlicensed medical product 7. Any medical reason why, in the opinion of the investigator, the patient should not participate in this study

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Other:
• Collection of blood
Blood collection
• Tissue Collection
Collection of tumour tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Achilles Therapeutics Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtaining samples for research	This protocol does not have an analysis primary outcome measure but rather will be conducted in accordance with GCP for human research, solely for the purpose of obtaining samples for research.	5 years