ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients

NCT06844136 | Recruiting DMC

• 1 other identifier: 201600013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-randomized, observational, clinical development study. Pierian Biosciences is utilizing ChemoINTEL and ImmunoINTEL assay measurements in human tumour cells from patients with advanced stage epithelial ovarian cancer (EOC) to develop a mathematical algorithm which will be able to predict a patient's tumour's sensitivity to specific chemotherapy drugs. The study involves using a sample of tumour biopsy taken during standard of care surgery, with a matched blood sample if possible. Medical history, pathology information and information on chemotherapy for up to 6 cycles will be requested. The information will then be used to developed an algorithm to predict tumour sensitivity to treatment.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Prediction Algorithm

  To develop a prediction algorithm that uses input from the ChemoINTEL and ImmunoINTEL assay metric results and provides an accurate prediction of a patient's cancer's sensitivity to specific chemotherapeutic agents by assessing the patient's response based on either RECIST criteria (v 1.1, 2009), CA-125 KELIM Score, and/or circulating tumor DNA changes to the administered chemotherapy following three cycles of SOC chemotherapy.

  2 years

Study Arms (3)

Group 1

De Novo (no prior cytotoxic therapy) receiving primary cytoreductive surgery and adjuvant chemotherapy

Other: No intervention

Group 2

De Novo (no prior cytotoxic therapy) receiving neoadjuvant chemotherapy and interval cytoreductive surgery followed by additional chemotherapy

Other: No intervention

Group 3

Recurrent (one or more prior lines of previous cytotoxic therapy) receiving next line of chemotherapy

Other: No intervention

Interventions

No intervention OTHER

No intervention

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female with ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ovarian cancer diagnosis

You may qualify if:

• Females ≥18 years of age
• Diagnosis by pathology of one of either advanced stage EOC, Primary Peritoneal Carcinomatosis, or Fallopian Tube Carcinoma
• Newly diagnosed
• Recurrent
• Patient provided an evaluable tumor or peritoneal fluid specimen prior to initiating chemotherapy for ChemoINTEL assay analysis
• Patient received at least 3 cycles of standard of care chemotherapy for advanced stage EOC with single agent or combination of drugs summarised as below, following biopsy OR surgical resection
• Carboplatin
• Cisplatin
• Cyclophosphamide-4HC active metabolite
• Docetaxel
• Doxorubicin
• Etoposide
• Fluorouracil
• Gemcitabine
• Ifosfamide-4HI active metabolite

You may not qualify if:

• Patient has not signed an ICF to participate in a clinical investigation
• Patient has a cancer other than advanced stage EOC
• Patient did NOT receive SOC chemotherapy, single agents or combination treatment from the indicated list above.
• Patients did NOT have sufficient viable cells recovered from either a fresh tumor dissociation or peritoneal fluid specimen collected prior to initiating chemotherapy available for the minimum ChemoINTEL assay analysis of Carboplatin, Cisplatin, Docetaxel, and Paclitaxel test conditions

Sponsors & Collaborators

• Pierian Biosciences: lead

Study Sites (1)

Liverpool Women's NHS Foundation Trust

Liverpool, Merseyside, L8 7SS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour Biopsy Blood sample Ascites fluids

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Robert Henry

  Pierian Biosciences Ltd

  STUDY DIRECTOR

Central Study Contacts

Norman Purvis, PhD

CONTACT

+44 (0)333 034 1690; npurvis@pierianbio.com

Maria Maguire, PhD

CONTACT

07824609720; maria.maguiire2@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: November 22, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)